Trial reportAmerican journal of respiratory and critical care medicine2008
Randomized clinical trial of activated protein C for the treatment of acute lung injury.
Trial report in American journal of respiratory and critical care medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 7 of them syntheses that pooled it.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
100 citing papers in PubMed, 7 syntheses or guidelines pooled it, 207 citations in OpenAlex.
- Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review.Critical care (London, England) · 2023Pooled it
- Expression of MicroRNAs in Sepsis-Related Organ Dysfunction: A Systematic Review.International journal of molecular sciences · 2022Pooled it
- Impact of differences in acute respiratory distress syndrome randomised controlled trial inclusion and exclusion criteria: systematic review and meta-analysis.British journal of anaesthesia · 2021Pooled it
- Between-trial heterogeneity in ARDS research.Intensive care medicine · 2021Pooled it
- Pharmacological agents for adults with acute respiratory distress syndrome.The Cochrane database of systematic reviews · 2019Pooled it
- Tidal volume and plateau pressure use for acute lung injury from 2000 to present: a systematic literature review.Critical care medicine · 2014Pooled it
- Nebulized anticoagulants for acute lung injury - a systematic review of preclinical and clinical investigations.Critical care (London, England) · 2012Pooled it
- Diminished plasma levels of GPIb-Frontiers in medicine · 2026Trial
- Trial
- The association between physiologic dead-space fraction and mortality in subjects with ARDS enrolled in a prospective multi-center clinical trial.Respiratory care · 2014Trial
- Recombinant human activated protein C in the treatment of acute respiratory distress syndrome: a randomized clinical trial.PloS one · 2014Trial
- Activated protein C attenuates pulmonary coagulopathy in patients with acute respiratory distress syndrome.Journal of thrombosis and haemostasis : JTH · 2013Trial
- Pathogenetic and predictive value of biomarkers in patients with ALI and lower severity of illness: results from two clinical trials.American journal of physiology. Lung cellular and molecular physiology · 2012Trial
- Trial
- A phase I study evaluating the pharmacokinetics, safety and tolerability of an antibody-based tissue factor antagonist in subjects with acute lung injury or acute respiratory distress syndrome.BMC pulmonary medicine · 2012Trial
- Effects of methylprednisolone infusion on markers of inflammation, coagulation, and angiogenesis in early acute respiratory distress syndrome.Critical care medicine · 2012Trial
- Alterations in the human lung proteome with lipopolysaccharide.BMC pulmonary medicine · 2009Trial
- Randomized clinical trial of activated protein C for the treatment of acute lung injury.American journal of respiratory and critical care medicine · 2008Trial
- Lung-Cardiovascular Interactions and Derangements in ARDS.Comprehensive physiology · 2026Review
- Endothelial barrier and sepsis: mechanisms and potential therapeutic strategies.Military Medical Research · 2026Review
40 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
16 authors at 7 institutions in 2 countries.
Funding
Abstract
rationaleMicrovascular injury, inflammation, and coagulation play critical roles in the pathogenesis of acute lung injury (ALI). Plasma protein C levels are decreased in patients with acute lung injury and are associated with higher mortality and fewer ventilator-free days.
objectivesTo test the efficacy of activated protein C (APC) as a therapy for patients with ALI.
methodsEligible subjects were critically ill patients who met the American/European consensus criteria for ALI. Patients with severe sepsis and an APACHE II score of 25 or more were excluded. Participants were randomized to receive APC (24 microg/kg/h for 96 h) or placebo in a double-blind fashion within 72 hours of the onset of ALI. The primary endpoint was ventilator-free days. MEASUREMENTS AND MAIN
resultsAPC increased plasma protein C levels (P = 0.002) and decreased pulmonary dead space fraction (P = 0.02). However, there was no statistically significant difference between patients receiving placebo (n = 38) or APC (n = 37) in the number of ventilator-free days (median [25-75% interquartile range]: 19 [0-24] vs. 19 [14-22], respectively; P = 0.78) or in 60-day mortality (5/38 vs. 5/37 patients, respectively; P = 1.0). There were no differences in the number of bleeding events between the two groups.
conclusionsAPC did not improve outcomes from ALI. The results of this trial do not support a large clinical trial of APC for ALI in the absence of severe sepsis and high disease severity.
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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 OpenQuestion graph.