Evidence map›Paper›PMID 26936876›Full record

Trial reportThorax2016

One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial.

Victor D Dinglas, Ramona O Hopkins, Amy W Wozniak, Catherine L Hough, Peter E Morris, James C Jackson, Pedro A Mendez-Tellez, O Joseph Bienvenu, E Wesley Ely, Elizabeth Colantuoni and 1 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thorax, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 7 pooled it
8.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00719446 completednot on this map

Patient Outcomes 6 and 12 Months After ALTA, OMEGA, EDEN and SAILS ARDS Network Trials

TypeobservationalSponsorJohns Hopkins UniversityRan2007 to 2014Enrolled922ConditionsRespiratory Distress Syndrome, Adult
NCT00979121 phase3terminatednot on this map

Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2010 to 2013Enrolled745ConditionsSepsis, Acute Lung InjuryArmsRosuvastatin, Placebo
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 7 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Statins for the primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2024
    Pooled it
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  6. Pharmacological agents for adults with acute respiratory distress syndrome.The Cochrane database of systematic reviews · 2019
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

Victor D DinglasOutcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ramona O HopkinsPulmonary and Critical Care Division, Department of Medicine, Intermountain Medical Center, Murray, Utah, USA Psychology Department and Neuroscience Center, Brigham Young University, Provo, Utah, USA Center for Humanizing Critical Care, Intermountain Health Care, Murray, Utah, USA.
Amy W WozniakOutcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Catherine L HoughDivision of Pulmonary and Critical Care Medicine, Harborview Medical Center, University of Washington, Seattle, Washington, USA.
Peter E MorrisDivision of Pulmonary, Critical Care & Sleep Medicine, University of Kentucky, Lexington, Kentucky, USA.
James C JacksonDivision of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Pedro A Mendez-TellezOutcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
O Joseph BienvenuOutcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
E Wesley ElyDivision of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA Geriatric Research, Education and Clinical Center Service, Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, Tennessee, USA.
Elizabeth ColantuoniOutcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Dale M NeedhamOutcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Johns Hopkins University · USJohns Hopkins Medicine · USHarborview Medical Center · USIntermountain Medical Center · USUniversity of Kentucky · USVanderbilt University · USVA Tennessee Valley Healthcare System · US

Funding

Institute for Clinical and Translational ResearchUL1TR000424 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2012 to 2012
$6.0M
Patient Outcomes 6 and 12 Months After ALTA, OMEGA and EDEN ARDS Network TrialsR01HL091760 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI HOPKINS, RAMONA O, NEEDHAM, DALE MURRAY · 2008 to 2011
$2.0M
VITAMIN C, GLUTATHIONE, AND ENDOTHELIAL CELL FUNCTIONR01HL056170 · NHLBI · OREGON STATE UNIVERSITY · PI FREI, BALZ B · 1996 to 1999
–
NCATS NIH HHS UL1 TR000424NCATS NIH HHS UL1 TR 000424-06NHLBI NIH HHS 3R01HL091760-02S1NHLBI NIH HHS N01 HR056170NHLBI NIH HHS R01 HL091760NHLBI NIH HHS R01HL091760
6 · The paper itself

Abstract

backgroundPrior randomised trials have evaluated statins in patients with sepsis and acute respiratory distress syndrome (ARDS), but there has been no comprehensive evaluation of long-term effects, despite potential neuromuscular and mental health adverse effects of these drugs.

aimTo evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS.

methodsProspective follow-up evaluation of the ARDS Clinical Trials Network Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo in 568 mechanically ventilated patients with sepsis-associated ARDS, with blinded 6-month outcome assessment performed in the 272 eligible survivors for age-adjusted and sex-adjusted 36-Item Short Form Health Survey (SF-36) physical function and mental health domains, and in 84 eligible survivors for the 6 min walk test, along with secondary outcomes evaluations of survival, and additional patient-reported and performance-based measures at 6-month and 12-month follow-up.

resultsOver 1-year follow-up, there was no significant difference in cumulative survival in the rosuvastatin versus placebo groups (58% vs 61%; p=0.377), with survivors demonstrating substantial impairments in physical function and mental health. Rosuvastatin versus placebo had no effect (mean treatment effect (95% CI)) on SF-36 physical function (0 (-7 to 8), p=0.939) or mental health (-6 (-12 to 1) p=0.085) domains, 6 min walk distance (per cent predicted: 2 (-9 to 14), p=0.679) or the vast majority of secondary outcomes.

conclusionsOver 1-year follow-up, patients with sepsis-associated ARDS had high cumulative mortality, with survivors commonly experiencing impairments in physical functioning and performance, and mental health. Randomisation to rosuvastatin had no effect on these outcomes. TRIAL REGISTRATION NUMBER: NCT00979121 and NCT00719446.

Indexed as

Exercise TestBody Mass IndexDiabetes ComplicationsFemaleFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsKaplan-Meier EstimateMaleMiddle AgedProspective StudiesQuality of LifeRespiratory Distress SyndromeRisk FactorsRosuvastatin CalciumSepsisHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumARDS

Identifiers

PMID26936876
PMCPMC6998199
OpenAlexW2290122435

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.