ArticleIntensive care medicine2008
Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock.
Article in Intensive care medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 38 papers, 3 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
38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Human recombinant protein C for severe sepsis and septic shock in adult and paediatric patients.The Cochrane database of systematic reviews · 2012Pooled it
- Recombinant human activated protein C for severe sepsis in neonates.The Cochrane database of systematic reviews · 2012Pooled it
- Prevention, diagnosis, therapy and follow-up care of sepsis: 1st revision of S-2k guidelines of the German Sepsis Society (Deutsche Sepsis-Gesellschaft e.V. (DSG)) and the German Interdisciplinary Association of Intensive Care and Emergency Medicine (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin (DIVI)).German medical science : GMS e-journal · 2010Guideline
- Impact of albumin compared to saline on organ function and mortality of patients with severe sepsis.Intensive care medicine · 2011Trial
- Old drug, new Trick? The rationale for the treatment of COVID-19 with activated protein C.Medical hypotheses · 2021Article
- Six subphenotypes in septic shock: Latent class analysis of the PROWESS Shock study.Journal of critical care · 2018Article
- The systemic immune response to pediatric thermal injury.International journal of burns and trauma · 2018Review
- Trials in adult critical care that show increased mortality of the new intervention: Inevitable or preventable mishaps?Annals of intensive care · 2016Article
- Observational
- Therapeutic Effects of Treatment with Anti-TLR2 and Anti-TLR4 Monoclonal Antibodies in Polymicrobial Sepsis.PloS one · 2015Article
- Current concept of abdominal sepsis: WSES position paper.World journal of emergency surgery : WJES · 2014Article
- The prognostic value of ADAMTS13 (a disintegrin and metalloprotease with thrombospondin type 1 repeats, member 13) deficiency in septic shock patients involves interleukin-6 and is not dependent on disseminated intravascular coagulation.Critical care (London, England) · 2013Article
- A dream deferred: the rise and fall of recombinant activated protein C.Critical care (London, England) · 2013Article
- Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).Clinical and translational science · 2013Article
- Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences.Critical care (London, England) · 2013Observational
- Evaluation of recombinant activated protein C for severe sepsis at a tertiary academic medical center.Therapeutics and clinical risk management · 2013Article
- Updates on role of human recombinant activated protein C in patients with sepsis and severe sepsis: Changed scenario after PROWESS SHOCK trial.Indian journal of anaesthesia · 2012Article
- Persistent hypocoagulability in patients with septic shock predicts greater hospital mortality: impact of impaired thrombin generation.Intensive care medicine · 2012Article
- Design, conduct, and analysis of a multicenter, pharmacogenomic, biomarker study in matched patients with severe sepsis treated with or without drotrecogin Alfa (activated).Annals of intensive care · 2012Article
- Sepsis: an update for physicians.Clinical medicine (London, England) · 2011Review
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
9 authors at 9 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The role of drotrecogin alfa (activated) (DAA) in severe sepsis remains controversial and clinicians are unsure whether or not to treat their patients with DAA. In response to a request from the European Medicines Agency, Eli Lilly will sponsor a new placebo-controlled trial and history suggests the results will be subject to great scrutiny. An academic steering committee will oversee the conduct of the study and will write the study manuscripts. The steering committee intends that the study will be conducted with the maximum possible transparency; this includes publication of the study protocol and a memorandum of understanding which delineates the role of the sponsor. The trial has the potential to provide clinicians with valuable data but patients will only benefit if clinicians have confidence in the conduct, analysis and reporting of the trial. This special article describes the process by which the trial was developed, major decisions regarding trial design, and plans for independent analysis, interpretation and reporting of the data.
Indexed as
Identifiers
What OpenQuestion holds
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.