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


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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.
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41 Consensus Conference definition
42 Controlled Trials
43 DesignPatients
44 Failure Assessment
45 ICU
46 Ireland
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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
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