Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2014-2018

ABSTRACT

The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters. Detailed Description Hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital. Elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction < 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively. Following written consent, the patients with left ventricular ejection fraction < 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance. Before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication. All the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative. The patients will be selected for more than 24 months. More... »

URL

https://clinicaltrials.gov/show/NCT02972918

Related SciGraph Publications

  • 2000-08. Risk of Mortality Following Clinical Fractures in OSTEOPOROSIS INTERNATIONAL
  • 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/2008/3048", 
            "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
            "type": "DefinedTerm"
          }, 
          {
            "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
            "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
            "type": "DefinedTerm"
          }
        ], 
        "description": "The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters.\n\nDetailed Description\nHip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital. Elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction < 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively. Following written consent, the patients with left ventricular ejection fraction < 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance. Before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication. All the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative. The patients will be selected for more than 24 months.", 
        "endDate": "2018-12-01T00:00:00Z", 
        "id": "sg:clinicaltrial.NCT02972918", 
        "keywords": [
          "heart failure patient", 
          "optimization", 
          "hip fracture", 
          "tissue perfusion", 
          "hip", 
          "fracture", 
          "entity", 
          "elderly patient", 
          "admission", 
          "hospital", 
          "patient", 
          "General Surgery", 
          "high risk", 
          "morbidity", 
          "mortality", 
          "cardiovascular complication", 
          "high morbidity", 
          "high incidence", 
          "failure", 
          "present study", 
          "cardiac function", 
          "left ventricular ejection fraction", 
          "cardiac morbidity", 
          "consent", 
          "resuscitation", 
          "anesthesia", 
          "intravenous injection", 
          "vigilance", 
          "echocardiography", 
          "myocardial function", 
          "NT-proBNP", 
          "sensor system", 
          "edward", 
          "Pulse Wave Analysis", 
          "parameter", 
          "stroke volume", 
          "cardiac index", 
          "Vascular Resistance", 
          "power", 
          "injection", 
          "initial dose", 
          "room", 
          "cardiac complication", 
          "ups"
        ], 
        "name": "Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture", 
        "sameAs": [
          "https://app.dimensions.ai/details/clinical_trial/NCT02972918"
        ], 
        "sdDataset": "clinical_trials", 
        "sdDatePublished": "2019-03-07T15:27", 
        "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
        "sdPublisher": {
          "name": "Springer Nature - SN SciGraph project", 
          "type": "Organization"
        }, 
        "sdSource": "file:///pack/app/us_ct_data_00023.json", 
        "sponsor": [
          {
            "id": "https://www.grid.ac/institutes/grid.411220.4", 
            "type": "Organization"
          }
        ], 
        "startDate": "2014-05-01T00:00:00Z", 
        "subjectOf": [
          {
            "id": "sg:pub.10.1007/s001980070075", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1001560227", 
              "https://doi.org/10.1007/s001980070075"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/s001980070075", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1001560227", 
              "https://doi.org/10.1007/s001980070075"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1111/j.1532-5415.2008.01945.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1012104716"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1017/s0265021508004080", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1043055220"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1016/s0140-6736(98)09075-8", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1049199489"
            ], 
            "type": "CreativeWork"
          }
        ], 
        "type": "MedicalStudy", 
        "url": "https://clinicaltrials.gov/show/NCT02972918"
      }
    ]
     

    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/clinicaltrial.NCT02972918'

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

    curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT02972918'

    Turtle is a human-readable linked data format.

    curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT02972918'

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

    curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT02972918'


     

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

    79 TRIPLES      16 PREDICATES      64 URIs      53 LITERALS      1 BLANK NODES

    Subject Predicate Object
    1 sg:clinicaltrial.NCT02972918 schema:about anzsrc-for:3048
    2 anzsrc-for:3053
    3 schema:description The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters. Detailed Description Hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital. Elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction < 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively. Following written consent, the patients with left ventricular ejection fraction < 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance. Before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication. All the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative. The patients will be selected for more than 24 months.
    4 schema:endDate 2018-12-01T00:00:00Z
    5 schema:keywords General Surgery
    6 NT-proBNP
    7 Pulse Wave Analysis
    8 Vascular Resistance
    9 admission
    10 anesthesia
    11 cardiac complication
    12 cardiac function
    13 cardiac index
    14 cardiac morbidity
    15 cardiovascular complication
    16 consent
    17 echocardiography
    18 edward
    19 elderly patient
    20 entity
    21 failure
    22 fracture
    23 heart failure patient
    24 high incidence
    25 high morbidity
    26 high risk
    27 hip
    28 hip fracture
    29 hospital
    30 initial dose
    31 injection
    32 intravenous injection
    33 left ventricular ejection fraction
    34 morbidity
    35 mortality
    36 myocardial function
    37 optimization
    38 parameter
    39 patient
    40 power
    41 present study
    42 resuscitation
    43 room
    44 sensor system
    45 stroke volume
    46 tissue perfusion
    47 ups
    48 vigilance
    49 schema:name Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture
    50 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT02972918
    51 schema:sdDatePublished 2019-03-07T15:27
    52 schema:sdLicense https://scigraph.springernature.com/explorer/license/
    53 schema:sdPublisher Nd3c67dcf4fd8488b9879ee391120ec2a
    54 schema:sponsor https://www.grid.ac/institutes/grid.411220.4
    55 schema:startDate 2014-05-01T00:00:00Z
    56 schema:subjectOf sg:pub.10.1007/s001980070075
    57 https://doi.org/10.1016/s0140-6736(98)09075-8
    58 https://doi.org/10.1017/s0265021508004080
    59 https://doi.org/10.1111/j.1532-5415.2008.01945.x
    60 schema:url https://clinicaltrials.gov/show/NCT02972918
    61 sgo:license sg:explorer/license/
    62 sgo:sdDataset clinical_trials
    63 rdf:type schema:MedicalStudy
    64 Nd3c67dcf4fd8488b9879ee391120ec2a schema:name Springer Nature - SN SciGraph project
    65 rdf:type schema:Organization
    66 anzsrc-for:3048 schema:inDefinedTermSet anzsrc-for:
    67 rdf:type schema:DefinedTerm
    68 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
    69 rdf:type schema:DefinedTerm
    70 sg:pub.10.1007/s001980070075 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001560227
    71 https://doi.org/10.1007/s001980070075
    72 rdf:type schema:CreativeWork
    73 https://doi.org/10.1016/s0140-6736(98)09075-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1049199489
    74 rdf:type schema:CreativeWork
    75 https://doi.org/10.1017/s0265021508004080 schema:sameAs https://app.dimensions.ai/details/publication/pub.1043055220
    76 rdf:type schema:CreativeWork
    77 https://doi.org/10.1111/j.1532-5415.2008.01945.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1012104716
    78 rdf:type schema:CreativeWork
    79 https://www.grid.ac/institutes/grid.411220.4 schema:Organization
     




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


    ...