Trial reportThe New England journal of medicine2012
Drotrecogin alfa (activated) in adults with septic shock.
Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 559 papers, 3 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.
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock
PILOT STUDY in the Use of Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis
Observational Trial on Cytokine Adsorption in Sepsis
Validation of a Point-of-care Device for Rapid Bedside Measurement of Circulating Nucleosome Levels in Critically Ill Patients and Study of Its Relevance to Prognostication
Efficacy, Safety, and Tolerability of Methylprednisolone in Critically Ill Patients With the Hyperinflammatory Phenotype: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial
Who cites it
559 citing papers in PubMed, 3 syntheses or guidelines pooled it, 1,272 citations in OpenAlex.
- Efficacy and safety of anticoagulant therapy in sepsis: A systematic review and meta-analysis.The Journal of international medical research · 2026Pooled it
- A Research Agenda for Precision Medicine in Sepsis and Acute Respiratory Distress Syndrome: An Official American Thoracic Society Research Statement.American journal of respiratory and critical care medicine · 2021Guideline
- Timing of norepinephrine initiation in patients with septic shock: a systematic review and meta-analysis.Critical care (London, England) · 2020Pooled it
- How the context of reception affects the meaning of RCT evidence.Health (London, England : 1997) · 2024Trial
- Clinical and biochemical endpoints and predictors of response to plasma exchange in septic shock: results from a randomized controlled trial.Critical care (London, England) · 2022Trial
- Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy.Critical care medicine · 2020Trial
- Nangibotide in patients with septic shock: a Phase 2a randomized controlled clinical trial.Intensive care medicine · 2020Trial
- Lung-Cardiovascular Interactions and Derangements in ARDS.Comprehensive physiology · 2026Review
- Polymyxin B hemoadsorption in endotoxic septic shock: ten questions on the Tigris trial.Critical care (London, England) · 2026Article
- Aberrant STAT signaling and T cell dysregulation define a targetable pediatric sepsis endotype.The Journal of clinical investigation · 2026Article
- Longitudinal blood transcriptome profiling reveals immune dynamics in sepsis.BMC infectious diseases · 2026Article
- Precision medicine in sepsis: lessons from the TIGRIS trial and the reawakening of targeted therapy.Journal of anesthesia, analgesia and critical care · 2026Review
- Fibrinolytic insufficiency in sepsis-associated DIC: shift the focus from PAI-1 to plasminogen degradation by NETs.Intensive care medicine · 2026Article
- Inherent safety risks of guidelines derived from "cause-agnostic" randomized controlled trials: a review.Patient safety in surgery · 2026Review
- Review
- Neonatal Sepsis-Induced Coagulopathy in the Light of Developmental Hemostasis: Friend or Foe?Medicina (Kaunas, Lithuania) · 2026Review
- Modulating Vimentin: A Systems-Level Therapeutic Strategy for Sepsis and Complex Diseases.Life (Basel, Switzerland) · 2026Article
- HDAC6 inhibition reprograms endothelial and macrophage responses to protect the lung in endotoxemia.Respiratory research · 2026Article
- Pediatric Sepsis: Evolving Subphenotypes, Overlap Syndromes, and the Path to Precision Therapies.Clinics in chest medicine · 2026Review
- Pre-existing systemic inflammation impairs bacterial clearance in the spleen.Intensive care medicine experimental · 2026Article
499 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
19 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere have been conflicting reports on the efficacy of recombinant human activated protein C, or drotrecogin alfa (activated) (DrotAA), for the treatment of patients with septic shock.
methodsIn this randomized, double-blind, placebo-controlled, multicenter trial, we assigned 1697 patients with infection, systemic inflammation, and shock who were receiving fluids and vasopressors above a threshold dose for 4 hours to receive either DrotAA (at a dose of 24 μg per kilogram of body weight per hour) or placebo for 96 hours. The primary outcome was death from any cause 28 days after randomization.
resultsAt 28 days, 223 of 846 patients (26.4%) in the DrotAA group and 202 of 834 (24.2%) in the placebo group had died (relative risk in the DrotAA group, 1.09; 95% confidence interval [CI], 0.92 to 1.28; P=0.31). At 90 days, 287 of 842 patients (34.1%) in the DrotAA group and 269 of 822 (32.7%) in the placebo group had died (relative risk, 1.04; 95% CI, 0.90 to 1.19; P=0.56). Among patients with severe protein C deficiency at baseline, 98 of 342 (28.7%) in the DrotAA group had died at 28 days, as compared with 102 of 331 (30.8%) in the placebo group (risk ratio, 0.93; 95% CI, 0.74 to 1.17; P=0.54). Similarly, rates of death at 28 and 90 days were not significantly different in other predefined subgroups, including patients at increased risk for death. Serious bleeding during the treatment period occurred in 10 patients in the DrotAA group and 8 in the placebo group (P=0.81).
conclusionsDrotAA did not significantly reduce mortality at 28 or 90 days, as compared with placebo, in patients with septic shock. (Funded by Eli Lilly; PROWESS-SHOCK ClinicalTrials.gov number, NCT00604214.).
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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.