Trial reportPloS one2014
Recombinant human activated protein C in the treatment of acute respiratory distress syndrome: a randomized clinical trial.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled 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.
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
21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- 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
- The efficacy of recombinant human soluble thrombomodulin (rhsTM) treatment for acute exacerbation of idiopathic pulmonary fibrosis: a systematic review and meta-analysis.BMC pulmonary medicine · 2020Pooled it
- Pharmacological agents for adults with acute respiratory distress syndrome.The Cochrane database of systematic reviews · 2019Pooled it
- Cellular Mechanisms of Lung Injury: Current Perspectives.Clinics in chest medicine · 2024Review
- Understanding Cellular Redox Homeostasis: A Challenge for Precision Medicine.International journal of molecular sciences · 2021Review
- Article
- Acute Respiratory Distress Syndrome and COVID-19: A Literature Review.Journal of inflammation research · 2021Review
- Coagulation Dysfunction in Acute Respiratory Distress Syndrome and Its Potential Impact in Inflammatory Subphenotypes.Frontiers in medicine · 2021Review
- Targeting coagulation activation in severe COVID-19 pneumonia: lessons from bacterial pneumonia and sepsis.European respiratory review : an official journal of the European Respiratory Society · 2020Review
- Pharmacological Agents Targeting Thromboinflammation in COVID-19: Review and Implications for Future Research.Thrombosis and haemostasis · 2020Review
- Nordihydroguaiaretic acid reduces secondary organ injury in septic rats after cecal ligation and puncture.PloS one · 2020Article
- Antithrombin plus alpha-1 protease inhibitor does not affect coagulation and inflammation in two murine models of acute lung injury.Intensive care medicine experimental · 2019Article
- Acute Respiratory Distress Syndrome: Bench-to-Bedside Approaches to Improve Drug Development.Clinical pharmacology and therapeutics · 2018Review
- Management and outcomes of acute respiratory distress syndrome patients with and without comorbid conditions.Intensive care medicine · 2018Article
- Activated Protein C has No Effect on Pulmonary Capillary Endothelial Function in Septic Patients with Acute Respiratory Distress Syndrome: Association of Endothelial Dysfunction with Mortality.Infectious diseases and therapy · 2018Article
- ROS Signaling in the Pathogenesis of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).Advances in experimental medicine and biology · 2017Article
- The clinical practice guideline for the management of ARDS in Japan.Journal of intensive care · 2017Article
- Prognostic factors in the acute respiratory distress syndrome.Clinical and translational medicine · 2015Article
- Human recombinant activated protein C-coated stent for the prevention of restenosis in porcine coronary arteries.Journal of materials science. Materials in medicine · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationalePulmonary coagulopathy may play a pathogenetic role in acute respiratory distress syndrome (ARDS), by contributing to alveolocapillary inflammation and increased permeability. Recombinant human activated protein C (rh-APC) may inhibit this process and thereby improve patient outcome.
methodsA prospective randomized, saline-controlled, single-blinded clinical trial was performed in the intensive care units of two university hospitals, and patients with ARDS were included within 24 h after meeting inclusion criteria.
interventionA 4-day course of intravenous rh-APC (24 mcg/kg/h) (n = 33) versus saline (n = 38). OUTCOMES: The primary outcome parameter was the pulmonary leak index (PLI) of 67Gallium-transferrin as a measure of alveolocapillary permeability and secondary outcomes were disease severity scores and ventilator-free days, among others.
resultsBaseline characteristics were similar; in 87% of patients the PLI was above normal and in 90% mechanical or non-invasive ventilation was instituted at a median lung injury score of 2.5. There was no evidence that Rh-APC treatment affected the PLI or attenuated lung injury and sequential organ failure assessment scores. Mean ventilator-free days amounted to 14 (rh-APC) and 12 days (saline, P = 0.35). 28-day mortality was 6% in rh-APC- and 18% in saline-treated patients (P = 0.12). There was no difference in bleeding events. The study was prematurely discontinued because rh-APC was withdrawn from the market.
conclusionThere is no evidence that treatment with intravenous rh-APC during 4 days for infectious or inflammatory ARDS ameliorates increased alveolocapillary permeability or the clinical course of ARDS patients. We cannot exclude underpowering.
trial registrationNederlands Trial Register ISRCTN 52566874.
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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.