Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial: study protocol for a randomized ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2012-09-17

AUTHORS

Daniel F McAuley, John G Laffey, Cecilia M O’Kane, Mark Cross, Gavin D Perkins, Lynn Murphy, Christine McNally, Grainne Crealey, Michael Stevenson, the HARP-2 investigators on behalf of the Irish Critical Care Trials Group

ABSTRACT

BackgroundAcute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI.Methods/DesignPatients fulfilling the American-European Consensus Conference Definition of ALI will be randomized in a 1:1 ratio to receive enteral simvastatin 80 mg or placebo once daily for a maximum of 28 days. Allocation to randomized groups will be stratified with respect to hospital of recruitment and vasopressor requirement. Data will be recorded by participating ICUs until hospital discharge, and surviving patients will be followed up by post at 3, 6 and 12 months post randomization. The primary outcome is number of ventilator-free days to day 28. Secondary outcomes are: change in oxygenation index and sequential organ failure assessment score up to day 28, number of non pulmonary organ failure free days to day 28, critical care unit mortality; hospital mortality; 28 day post randomization mortality and 12 month post randomization mortality; health related quality of life at discharge, 3, 6 and 12 months post randomization; length of critical care unit and hospital stay; health service use up to 12 months post-randomization; and safety. A total of 540 patients will be recruited from approximately 35 ICUs in the UK and Ireland. An economic evaluation will be conducted alongside the trial. Plasma and urine samples will be taken up to day 28 to investigate potential mechanisms by which simvastatin might act to improve clinical outcomes.Trial registrationCurrent Controlled Trials ISRCTN88244364. More... »

PAGES

170

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1745-6215-13-170

DOI

http://dx.doi.org/10.1186/1745-6215-13-170

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1053650185

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/22985805


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Acute Lung Injury", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Clinical Protocols", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Cost-Benefit Analysis", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Double-Blind Method", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Costs", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Hospital Costs", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Hospital Mortality", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Hydroxymethylglutaryl-CoA Reductase Inhibitors", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Ireland", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Length of Stay", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Lung", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Prospective Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Quality of Life", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Recovery of Function", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Research Design", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Respiration, Artificial", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Simvastatin", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Time Factors", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Treatment Outcome", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "United Kingdom", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK", 
          "id": "http://www.grid.ac/institutes/grid.416232.0", 
          "name": [
            "Centre for Infection and Immunity, Queen's University of Belfast, BT9 7BL, Belfast, UK", 
            "Regional Intensive Care Unit, Royal Victoria Hospital, BT12 6BA, Belfast, UK", 
            "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "McAuley", 
        "givenName": "Daniel F", 
        "id": "sg:person.013052706317.18", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.013052706317.18"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Anaesthesia, Clinical Sciences Institute, National University of Ireland, Galway, Ireland", 
          "id": "http://www.grid.ac/institutes/grid.6142.1", 
          "name": [
            "Department of Anaesthesia, Clinical Sciences Institute, National University of Ireland, Galway, Ireland"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Laffey", 
        "givenName": "John G", 
        "id": "sg:person.01354366050.28", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01354366050.28"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Centre for Infection and Immunity, Queen's University of Belfast, BT9 7BL, Belfast, UK", 
          "id": "http://www.grid.ac/institutes/grid.4777.3", 
          "name": [
            "Centre for Infection and Immunity, Queen's University of Belfast, BT9 7BL, Belfast, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "O\u2019Kane", 
        "givenName": "Cecilia M", 
        "id": "sg:person.0706061252.72", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0706061252.72"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Regional Intensive Care Unit, Royal Victoria Hospital, BT12 6BA, Belfast, UK", 
          "id": "http://www.grid.ac/institutes/grid.416232.0", 
          "name": [
            "Centre for Infection and Immunity, Queen's University of Belfast, BT9 7BL, Belfast, UK", 
            "Regional Intensive Care Unit, Royal Victoria Hospital, BT12 6BA, Belfast, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Cross", 
        "givenName": "Mark", 
        "id": "sg:person.01340304604.87", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01340304604.87"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Warwick Medical School Clinical Trials Unit, University of Warwick, CV4 7AL, Warwick, UK", 
          "id": "http://www.grid.ac/institutes/grid.7372.1", 
          "name": [
            "Warwick Medical School Clinical Trials Unit, University of Warwick, CV4 7AL, Warwick, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Perkins", 
        "givenName": "Gavin D", 
        "id": "sg:person.01243160227.13", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01243160227.13"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK", 
          "id": "http://www.grid.ac/institutes/grid.416232.0", 
          "name": [
            "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Murphy", 
        "givenName": "Lynn", 
        "id": "sg:person.0606674501.99", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0606674501.99"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK", 
          "id": "http://www.grid.ac/institutes/grid.416232.0", 
          "name": [
            "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "McNally", 
        "givenName": "Christine", 
        "id": "sg:person.0731127104.06", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0731127104.06"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK", 
          "id": "http://www.grid.ac/institutes/grid.416232.0", 
          "name": [
            "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Crealey", 
        "givenName": "Grainne", 
        "id": "sg:person.01347624635.27", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01347624635.27"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK", 
          "id": "http://www.grid.ac/institutes/grid.416232.0", 
          "name": [
            "Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Stevenson", 
        "givenName": "Michael", 
        "id": "sg:person.01157733140.08", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01157733140.08"
        ], 
        "type": "Person"
      }, 
      {
        "familyName": "the HARP-2 investigators on behalf of the Irish Critical Care Trials Group", 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1186/1756-0500-2-77", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041843082", 
          "https://doi.org/10.1186/1756-0500-2-77"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00134-006-0080-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050889788", 
          "https://doi.org/10.1007/s00134-006-0080-2"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00134-009-1421-8", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1016986188", 
          "https://doi.org/10.1007/s00134-009-1421-8"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1745-6215-11-32", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1029353690", 
          "https://doi.org/10.1186/1745-6215-11-32"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00134-003-2022-6", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1030320231", 
          "https://doi.org/10.1007/s00134-003-2022-6"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/cc6808", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1011975658", 
          "https://doi.org/10.1186/cc6808"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2012-09-17", 
    "datePublishedReg": "2012-09-17", 
    "description": "BackgroundAcute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI.Methods/DesignPatients fulfilling the American-European Consensus Conference Definition of ALI will be randomized in a 1:1 ratio to receive enteral simvastatin 80 mg or placebo once daily for a maximum of 28 days. Allocation to randomized groups will be stratified with respect to hospital of recruitment and vasopressor requirement. Data will be recorded by participating ICUs until hospital discharge, and surviving patients will be followed up by post at 3, 6 and 12 months post randomization. The primary outcome is number of ventilator-free days to day 28. Secondary outcomes are: change in oxygenation index and sequential organ failure assessment score up to day 28, number of non pulmonary organ failure free days to day 28, critical care unit mortality; hospital mortality; 28 day post randomization mortality and 12 month post randomization mortality; health related quality of life at discharge, 3, 6 and 12 months post randomization; length of critical care unit and hospital stay; health service use up to 12 months post-randomization; and safety. A total of 540 patients will be recruited from approximately 35 ICUs in the UK and Ireland. An economic evaluation will be conducted alongside the trial. Plasma and urine samples will be taken up to day 28 to investigate potential mechanisms by which simvastatin might act to improve clinical outcomes.Trial registrationCurrent Controlled Trials ISRCTN88244364.", 
    "genre": "article", 
    "id": "sg:pub.10.1186/1745-6215-13-170", 
    "isAccessibleForFree": true, 
    "isFundedItemOf": [
      {
        "id": "sg:grant.2784459", 
        "type": "MonetaryGrant"
      }
    ], 
    "isPartOf": [
      {
        "id": "sg:journal.1297400", 
        "issn": [
          "1468-6708", 
          "1745-6215"
        ], 
        "name": "Trials", 
        "publisher": "Springer Nature", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "13"
      }
    ], 
    "keywords": [
      "acute lung injury", 
      "lung injury", 
      "day 28", 
      "clinical outcomes", 
      "American-European Consensus Conference definition", 
      "life-threatening respiratory failure", 
      "Sequential Organ Failure Assessment", 
      "organ failure-free days", 
      "placebo-controlled clinical trial", 
      "devastating clinical syndrome", 
      "hospital of recruitment", 
      "months post randomization", 
      "ventilator-free days", 
      "Organ Failure Assessment", 
      "multiple organ failure", 
      "Consensus Conference definition", 
      "health service use", 
      "pre-clinical data", 
      "critical care units", 
      "reductase inhibition", 
      "quality of life", 
      "vasopressor requirement", 
      "hospital mortality", 
      "respiratory failure", 
      "oxygenation index", 
      "unit mortality", 
      "hospital stay", 
      "hospital discharge", 
      "Secondary outcomes", 
      "organ failure", 
      "primary outcome", 
      "Controlled Trials", 
      "mechanical ventilation", 
      "care unit", 
      "clinical syndrome", 
      "study protocol", 
      "clinical trials", 
      "post randomization", 
      "randomized groups", 
      "service use", 
      "animal studies", 
      "simvastatin", 
      "patients", 
      "mortality", 
      "trials", 
      "injury", 
      "urine samples", 
      "free days", 
      "potential mechanisms", 
      "Failure Assessment", 
      "ICU", 
      "outcomes", 
      "months", 
      "days", 
      "randomization", 
      "economic evaluation", 
      "inhibition", 
      "multicenter", 
      "DesignPatients", 
      "placebo", 
      "statins", 
      "failure", 
      "stay", 
      "syndrome", 
      "hospital", 
      "ventilation", 
      "treatment", 
      "total", 
      "discharge", 
      "health", 
      "safety", 
      "group", 
      "recruitment", 
      "assessment", 
      "Ali", 
      "index", 
      "data", 
      "plasma", 
      "evaluation", 
      "study", 
      "life", 
      "protocol", 
      "number", 
      "post", 
      "hypothesis", 
      "changes", 
      "mechanism", 
      "use", 
      "UK", 
      "samples", 
      "quality", 
      "units", 
      "ratio", 
      "length", 
      "Ireland", 
      "definition", 
      "respect", 
      "maximum", 
      "allocation", 
      "requirements"
    ], 
    "name": "Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial: study protocol for a randomized controlled trial", 
    "pagination": "170", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1053650185"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/1745-6215-13-170"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "22985805"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/1745-6215-13-170", 
      "https://app.dimensions.ai/details/publication/pub.1053650185"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2022-09-02T15:55", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20220902/entities/gbq_results/article/article_571.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://doi.org/10.1186/1745-6215-13-170"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/1745-6215-13-170'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/1745-6215-13-170'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/1745-6215-13-170'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/1745-6215-13-170'


 

This table displays all metadata directly associated to this object as RDF triples.

343 TRIPLES      21 PREDICATES      152 URIs      138 LITERALS      28 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/1745-6215-13-170 schema:about N01fa659cf1754edc9e5aa61b1afec090
2 N03ddd8d7e9ab4454b5cae55a6bac85a5
3 N09ccd96421744cc88edea5c1d872e3f0
4 N1419c9e3c88c4677ba0678469f0356a2
5 N17bd9574aedd46fba1bca1651e586982
6 N4ace3a7a3e3246f3925d238a2d4a0b5b
7 N547cb65777004dec921b294255cff7b3
8 N673b67b10f604a229854d556bd74f258
9 N7359286f8f504c549bdd1a7b51c3c91a
10 N7cb74e0ab76f473991f70d697974ca4e
11 N826e3c9982e34706b5dd98f66a5d4c7f
12 N9bf3158e1ea24292bbcce3a7b5240822
13 Na3975a5c72ad4f5891266e79deb513d0
14 Na6958b1219fb4ce1a8d372828b9c6f09
15 Na720ba258ecb417684656b83f1b7950d
16 Nbc057a69c63e440b911c321d36d9bbfc
17 Nd247ea2165b54cd4b758fb3ccec0669b
18 Nd74c2cd6e2c546ce83a5866706abc3a1
19 Nd765615bef6646179f2a361e633cb204
20 Nd82b2720d2df4d528c1fd644dd48b2e2
21 Ndc603a39ed0b4374bf7186f7d15e2a2f
22 anzsrc-for:11
23 anzsrc-for:1103
24 schema:author N52f055e8a02a4c2992a2158193d7c1b5
25 schema:citation sg:pub.10.1007/s00134-003-2022-6
26 sg:pub.10.1007/s00134-006-0080-2
27 sg:pub.10.1007/s00134-009-1421-8
28 sg:pub.10.1186/1745-6215-11-32
29 sg:pub.10.1186/1756-0500-2-77
30 sg:pub.10.1186/cc6808
31 schema:datePublished 2012-09-17
32 schema:datePublishedReg 2012-09-17
33 schema:description BackgroundAcute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI.Methods/DesignPatients fulfilling the American-European Consensus Conference Definition of ALI will be randomized in a 1:1 ratio to receive enteral simvastatin 80 mg or placebo once daily for a maximum of 28 days. Allocation to randomized groups will be stratified with respect to hospital of recruitment and vasopressor requirement. Data will be recorded by participating ICUs until hospital discharge, and surviving patients will be followed up by post at 3, 6 and 12 months post randomization. The primary outcome is number of ventilator-free days to day 28. Secondary outcomes are: change in oxygenation index and sequential organ failure assessment score up to day 28, number of non pulmonary organ failure free days to day 28, critical care unit mortality; hospital mortality; 28 day post randomization mortality and 12 month post randomization mortality; health related quality of life at discharge, 3, 6 and 12 months post randomization; length of critical care unit and hospital stay; health service use up to 12 months post-randomization; and safety. A total of 540 patients will be recruited from approximately 35 ICUs in the UK and Ireland. An economic evaluation will be conducted alongside the trial. Plasma and urine samples will be taken up to day 28 to investigate potential mechanisms by which simvastatin might act to improve clinical outcomes.Trial registrationCurrent Controlled Trials ISRCTN88244364.
34 schema:genre article
35 schema:isAccessibleForFree true
36 schema:isPartOf N84e9e520ea8d4440abf2fd02b7bbddd8
37 N8e6eb0b970e04ed29d0c851b339047a9
38 sg:journal.1297400
39 schema:keywords Ali
40 American-European Consensus Conference definition
41 Consensus Conference definition
42 Controlled Trials
43 DesignPatients
44 Failure Assessment
45 ICU
46 Ireland
47 Organ Failure Assessment
48 Secondary outcomes
49 Sequential Organ Failure Assessment
50 UK
51 acute lung injury
52 allocation
53 animal studies
54 assessment
55 care unit
56 changes
57 clinical outcomes
58 clinical syndrome
59 clinical trials
60 critical care units
61 data
62 day 28
63 days
64 definition
65 devastating clinical syndrome
66 discharge
67 economic evaluation
68 evaluation
69 failure
70 free days
71 group
72 health
73 health service use
74 hospital
75 hospital discharge
76 hospital mortality
77 hospital of recruitment
78 hospital stay
79 hypothesis
80 index
81 inhibition
82 injury
83 length
84 life
85 life-threatening respiratory failure
86 lung injury
87 maximum
88 mechanical ventilation
89 mechanism
90 months
91 months post randomization
92 mortality
93 multicenter
94 multiple organ failure
95 number
96 organ failure
97 organ failure-free days
98 outcomes
99 oxygenation index
100 patients
101 placebo
102 placebo-controlled clinical trial
103 plasma
104 post
105 post randomization
106 potential mechanisms
107 pre-clinical data
108 primary outcome
109 protocol
110 quality
111 quality of life
112 randomization
113 randomized groups
114 ratio
115 recruitment
116 reductase inhibition
117 requirements
118 respect
119 respiratory failure
120 safety
121 samples
122 service use
123 simvastatin
124 statins
125 stay
126 study
127 study protocol
128 syndrome
129 total
130 treatment
131 trials
132 unit mortality
133 units
134 urine samples
135 use
136 vasopressor requirement
137 ventilation
138 ventilator-free days
139 schema:name Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial: study protocol for a randomized controlled trial
140 schema:pagination 170
141 schema:productId N63b3e39229d34bb4946905fda12a5511
142 Nb86f1c085c904160bd0d2d0481624de8
143 Nf17c23fe22f84b5f805f046a23f026e4
144 schema:sameAs https://app.dimensions.ai/details/publication/pub.1053650185
145 https://doi.org/10.1186/1745-6215-13-170
146 schema:sdDatePublished 2022-09-02T15:55
147 schema:sdLicense https://scigraph.springernature.com/explorer/license/
148 schema:sdPublisher Na53cd29504d944eea485208147587052
149 schema:url https://doi.org/10.1186/1745-6215-13-170
150 sgo:license sg:explorer/license/
151 sgo:sdDataset articles
152 rdf:type schema:ScholarlyArticle
153 N002866e17a8849368069356dd561a0dc rdf:first sg:person.01243160227.13
154 rdf:rest N27dec719270e4d04ab8567c1debdb7d8
155 N01fa659cf1754edc9e5aa61b1afec090 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
156 schema:name Hydroxymethylglutaryl-CoA Reductase Inhibitors
157 rdf:type schema:DefinedTerm
158 N03ddd8d7e9ab4454b5cae55a6bac85a5 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
159 schema:name Respiration, Artificial
160 rdf:type schema:DefinedTerm
161 N09ccd96421744cc88edea5c1d872e3f0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
162 schema:name Treatment Outcome
163 rdf:type schema:DefinedTerm
164 N1419c9e3c88c4677ba0678469f0356a2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
165 schema:name Drug Costs
166 rdf:type schema:DefinedTerm
167 N17bd9574aedd46fba1bca1651e586982 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
168 schema:name Cost-Benefit Analysis
169 rdf:type schema:DefinedTerm
170 N18d59ceefb634572ae45017d43698d8b rdf:first sg:person.0731127104.06
171 rdf:rest N9e5f1a2119654d5f9744460eed55ed40
172 N27dec719270e4d04ab8567c1debdb7d8 rdf:first sg:person.0606674501.99
173 rdf:rest N18d59ceefb634572ae45017d43698d8b
174 N4ace3a7a3e3246f3925d238a2d4a0b5b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
175 schema:name Research Design
176 rdf:type schema:DefinedTerm
177 N52f055e8a02a4c2992a2158193d7c1b5 rdf:first sg:person.013052706317.18
178 rdf:rest Nca1f0e9b715845c1b3f73bcb8f333a15
179 N547cb65777004dec921b294255cff7b3 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
180 schema:name Time Factors
181 rdf:type schema:DefinedTerm
182 N63b3e39229d34bb4946905fda12a5511 schema:name pubmed_id
183 schema:value 22985805
184 rdf:type schema:PropertyValue
185 N673b67b10f604a229854d556bd74f258 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
186 schema:name Clinical Protocols
187 rdf:type schema:DefinedTerm
188 N7359286f8f504c549bdd1a7b51c3c91a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
189 schema:name United Kingdom
190 rdf:type schema:DefinedTerm
191 N761c2341b3d84354b0a0b4b1b48f9290 rdf:first sg:person.0706061252.72
192 rdf:rest Nf16eb38f3c8f4a65bd0773a56badd79f
193 N7655a6ecdfcb4936bf857014aed034ab schema:familyName the HARP-2 investigators on behalf of the Irish Critical Care Trials Group
194 rdf:type schema:Person
195 N7cb74e0ab76f473991f70d697974ca4e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
196 schema:name Hospital Mortality
197 rdf:type schema:DefinedTerm
198 N826e3c9982e34706b5dd98f66a5d4c7f schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
199 schema:name Humans
200 rdf:type schema:DefinedTerm
201 N84e9e520ea8d4440abf2fd02b7bbddd8 schema:volumeNumber 13
202 rdf:type schema:PublicationVolume
203 N8e6eb0b970e04ed29d0c851b339047a9 schema:issueNumber 1
204 rdf:type schema:PublicationIssue
205 N9bf3158e1ea24292bbcce3a7b5240822 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
206 schema:name Double-Blind Method
207 rdf:type schema:DefinedTerm
208 N9e5f1a2119654d5f9744460eed55ed40 rdf:first sg:person.01347624635.27
209 rdf:rest Nab3521090da84ce491dab52bf7aaca62
210 Na3975a5c72ad4f5891266e79deb513d0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
211 schema:name Acute Lung Injury
212 rdf:type schema:DefinedTerm
213 Na53cd29504d944eea485208147587052 schema:name Springer Nature - SN SciGraph project
214 rdf:type schema:Organization
215 Na6958b1219fb4ce1a8d372828b9c6f09 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
216 schema:name Length of Stay
217 rdf:type schema:DefinedTerm
218 Na720ba258ecb417684656b83f1b7950d schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
219 schema:name Prospective Studies
220 rdf:type schema:DefinedTerm
221 Nab3521090da84ce491dab52bf7aaca62 rdf:first sg:person.01157733140.08
222 rdf:rest Nd5fe0786e3bc47748cbf192a9fdc1dba
223 Nb86f1c085c904160bd0d2d0481624de8 schema:name dimensions_id
224 schema:value pub.1053650185
225 rdf:type schema:PropertyValue
226 Nbc057a69c63e440b911c321d36d9bbfc schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
227 schema:name Recovery of Function
228 rdf:type schema:DefinedTerm
229 Nca1f0e9b715845c1b3f73bcb8f333a15 rdf:first sg:person.01354366050.28
230 rdf:rest N761c2341b3d84354b0a0b4b1b48f9290
231 Nd247ea2165b54cd4b758fb3ccec0669b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
232 schema:name Simvastatin
233 rdf:type schema:DefinedTerm
234 Nd5fe0786e3bc47748cbf192a9fdc1dba rdf:first N7655a6ecdfcb4936bf857014aed034ab
235 rdf:rest rdf:nil
236 Nd74c2cd6e2c546ce83a5866706abc3a1 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
237 schema:name Ireland
238 rdf:type schema:DefinedTerm
239 Nd765615bef6646179f2a361e633cb204 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
240 schema:name Hospital Costs
241 rdf:type schema:DefinedTerm
242 Nd82b2720d2df4d528c1fd644dd48b2e2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
243 schema:name Lung
244 rdf:type schema:DefinedTerm
245 Ndc603a39ed0b4374bf7186f7d15e2a2f schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
246 schema:name Quality of Life
247 rdf:type schema:DefinedTerm
248 Nf16eb38f3c8f4a65bd0773a56badd79f rdf:first sg:person.01340304604.87
249 rdf:rest N002866e17a8849368069356dd561a0dc
250 Nf17c23fe22f84b5f805f046a23f026e4 schema:name doi
251 schema:value 10.1186/1745-6215-13-170
252 rdf:type schema:PropertyValue
253 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
254 schema:name Medical and Health Sciences
255 rdf:type schema:DefinedTerm
256 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
257 schema:name Clinical Sciences
258 rdf:type schema:DefinedTerm
259 sg:grant.2784459 http://pending.schema.org/fundedItem sg:pub.10.1186/1745-6215-13-170
260 rdf:type schema:MonetaryGrant
261 sg:journal.1297400 schema:issn 1468-6708
262 1745-6215
263 schema:name Trials
264 schema:publisher Springer Nature
265 rdf:type schema:Periodical
266 sg:person.01157733140.08 schema:affiliation grid-institutes:grid.416232.0
267 schema:familyName Stevenson
268 schema:givenName Michael
269 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01157733140.08
270 rdf:type schema:Person
271 sg:person.01243160227.13 schema:affiliation grid-institutes:grid.7372.1
272 schema:familyName Perkins
273 schema:givenName Gavin D
274 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01243160227.13
275 rdf:type schema:Person
276 sg:person.013052706317.18 schema:affiliation grid-institutes:grid.416232.0
277 schema:familyName McAuley
278 schema:givenName Daniel F
279 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.013052706317.18
280 rdf:type schema:Person
281 sg:person.01340304604.87 schema:affiliation grid-institutes:grid.416232.0
282 schema:familyName Cross
283 schema:givenName Mark
284 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01340304604.87
285 rdf:type schema:Person
286 sg:person.01347624635.27 schema:affiliation grid-institutes:grid.416232.0
287 schema:familyName Crealey
288 schema:givenName Grainne
289 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01347624635.27
290 rdf:type schema:Person
291 sg:person.01354366050.28 schema:affiliation grid-institutes:grid.6142.1
292 schema:familyName Laffey
293 schema:givenName John G
294 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01354366050.28
295 rdf:type schema:Person
296 sg:person.0606674501.99 schema:affiliation grid-institutes:grid.416232.0
297 schema:familyName Murphy
298 schema:givenName Lynn
299 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0606674501.99
300 rdf:type schema:Person
301 sg:person.0706061252.72 schema:affiliation grid-institutes:grid.4777.3
302 schema:familyName O’Kane
303 schema:givenName Cecilia M
304 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0706061252.72
305 rdf:type schema:Person
306 sg:person.0731127104.06 schema:affiliation grid-institutes:grid.416232.0
307 schema:familyName McNally
308 schema:givenName Christine
309 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0731127104.06
310 rdf:type schema:Person
311 sg:pub.10.1007/s00134-003-2022-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1030320231
312 https://doi.org/10.1007/s00134-003-2022-6
313 rdf:type schema:CreativeWork
314 sg:pub.10.1007/s00134-006-0080-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050889788
315 https://doi.org/10.1007/s00134-006-0080-2
316 rdf:type schema:CreativeWork
317 sg:pub.10.1007/s00134-009-1421-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1016986188
318 https://doi.org/10.1007/s00134-009-1421-8
319 rdf:type schema:CreativeWork
320 sg:pub.10.1186/1745-6215-11-32 schema:sameAs https://app.dimensions.ai/details/publication/pub.1029353690
321 https://doi.org/10.1186/1745-6215-11-32
322 rdf:type schema:CreativeWork
323 sg:pub.10.1186/1756-0500-2-77 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041843082
324 https://doi.org/10.1186/1756-0500-2-77
325 rdf:type schema:CreativeWork
326 sg:pub.10.1186/cc6808 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011975658
327 https://doi.org/10.1186/cc6808
328 rdf:type schema:CreativeWork
329 grid-institutes:grid.416232.0 schema:alternateName Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK
330 Regional Intensive Care Unit, Royal Victoria Hospital, BT12 6BA, Belfast, UK
331 schema:name Centre for Infection and Immunity, Queen's University of Belfast, BT9 7BL, Belfast, UK
332 Clinical Research Support Centre, Royal Victoria Hospital, BT12 6BA, Belfast, UK
333 Regional Intensive Care Unit, Royal Victoria Hospital, BT12 6BA, Belfast, UK
334 rdf:type schema:Organization
335 grid-institutes:grid.4777.3 schema:alternateName Centre for Infection and Immunity, Queen's University of Belfast, BT9 7BL, Belfast, UK
336 schema:name Centre for Infection and Immunity, Queen's University of Belfast, BT9 7BL, Belfast, UK
337 rdf:type schema:Organization
338 grid-institutes:grid.6142.1 schema:alternateName Department of Anaesthesia, Clinical Sciences Institute, National University of Ireland, Galway, Ireland
339 schema:name Department of Anaesthesia, Clinical Sciences Institute, National University of Ireland, Galway, Ireland
340 rdf:type schema:Organization
341 grid-institutes:grid.7372.1 schema:alternateName Warwick Medical School Clinical Trials Unit, University of Warwick, CV4 7AL, Warwick, UK
342 schema:name Warwick Medical School Clinical Trials Unit, University of Warwick, CV4 7AL, Warwick, UK
343 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...