ReviewJournal of intensive care2016
Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure.
Review in Journal of intensive care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03334006 (Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis), which is not on this map. Cited by 27 papers, 1 of them a synthesis 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.
Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.
- Efficacy and Safety of Hydrocortisone, Ascorbic Acid, and Thiamine Combination Therapy for the Management of Sepsis and Septic Shock: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.International archives of allergy and immunology · 2024Pooled it
- Gram-negative bacterial infection randomized controlled trials (RCTs) in the 21st century: characteristics and evolution.JAC-antimicrobial resistance · 2026Review
- Review
- Reframing sepsis immunobiology for translation: towards informative subtyping and targeted immunomodulatory therapies.The Lancet. Respiratory medicine · 2024Review
- Review
- SC2sepsis: sepsis single-cell whole gene expression database.Database : the journal of biological databases and curation · 2022Article
- Efficacy and Safety of Vilobelimab (IFX-1), a Novel Monoclonal Anti-C5a Antibody, in Patients With Early Severe Sepsis or Septic Shock-A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase IIa Trial (SCIENS Study).Critical care explorations · 2021Article
- Monitoring circulating dipeptidyl peptidase 3 (DPP3) predicts improvement of organ failure and survival in sepsis: a prospective observational multinational study.Critical care (London, England) · 2021Observational
- Transglutaminase 2 as a Marker for Inflammation and Therapeutic Target in Sepsis.International journal of molecular sciences · 2021Review
- Staging and Personalized Intervention for Infection and Sepsis.Surgical infections · 2020Review
- Levosimendan Efficacy and Safety: 20 Years of SIMDAX in Clinical Use.Journal of cardiovascular pharmacology · 2020Review
- Levosimendan Efficacy and Safety: 20 years of SIMDAX in Clinical Use.Cardiac failure review · 2020Review
- Recombinant human milk fat globule-EGF factor VIII (rhMFG-E8) as a therapy for sepsis after acute exposure to alcohol.Molecular medicine (Cambridge, Mass.) · 2019Article
- High mobility group box protein 1 neutralization therapy in ovine bacteremia: Lessons learned from an ovine septic shock model incorporating intensive care support.Experimental and therapeutic medicine · 2019Article
- Exploring the Protective Role and the Mechanism of Sphingosine 1 Phosphate in Endotoxic Cardiomyocytes.Shock (Augusta, Ga.) · 2019Article
- Association of Age With Short-term and Long-term Mortality Among Patients Discharged From Intensive Care Units in France.JAMA network open · 2019Observational
- Article
- Association between fluid overload and SOFA score kinetics in septic shock patients: a retrospective multicenter study.Journal of intensive care · 2019Article
- Six subphenotypes in septic shock: Latent class analysis of the PROWESS Shock study.Journal of critical care · 2018Article
- Precision Immunotherapy for Sepsis.Frontiers in immunology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 15 institutions in 8 countries.
Funding
Abstract
Substantial attention and resources have been directed to improving outcomes of patients with critical illnesses, in particular sepsis, but all recent clinical trials testing various interventions or strategies have failed to detect a robust benefit on mortality. Acute heart failure is also a critical illness, and although the underlying etiologies differ, acute heart failure and sepsis are critical care illnesses that have a high mortality in which clinical trials have been difficult to conduct and have not yielded effective treatments. Both conditions represent a syndrome that is often difficult to define with a wide variation in patient characteristics, presentation, and standard management across institutions. Referring to past experiences and lessons learned in acute heart failure may be informative and help frame research in the area of sepsis. Academic heart failure investigators and industry have worked closely with regulators for many years to transition acute heart failure trials away from relying on dyspnea assessments and all-cause mortality as the primary measures of efficacy, and recent trials have been designed to assess novel clinical composite endpoints assessing organ dysfunction and mortality while still assessing all-cause mortality as a separate measure of safety. Applying the lessons learned in acute heart failure trials to severe sepsis and septic shock trials might be useful to advance the field. Novel endpoints beyond all-cause mortality should be considered for future sepsis trials.
Indexed as
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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.