ReviewJournal of thoracic disease2020
Time to stop randomized and large pragmatic trials for intensive care medicine syndromes: the case of sepsis and acute respiratory distress syndrome.
Review in Journal of thoracic disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04742764 (Dosing of Extracorporeal Cytokine Removal In Septic Shock), which is not on this map. Cited by 18 papers, 2 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.
Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): a Prospective, Randomized, Multicenter Clinical Trial
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Research without prior consent procedure and intervention effect on mortality in critical care: a meta-epidemiological study of randomized controlled trials.Critical care (London, England) · 2025Pooled it
- COVID-19, corticosteroids and public health: a reappraisal.Public health · 2021Pooled it
- [Personalized sepsis therapy and modern trial designs].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2026Article
- Innovation in sepsis trials: rethinking endpoints, statistics and patient stratification.Intensive care medicine experimental · 2026Review
- Blood pressure and heart failure: focused on treatment.Clinical hypertension · 2024Review
- Systematic review with expert consensus on use of extracorporeal hemoadsorption in septic shock: An Indian perspective.World journal of critical care medicine · 2024Article
- Randomised clinical trials in critical care: past, present and future.Intensive care medicine · 2022Review
- Applicability of Vasopressor Trials in Adult Critical Care: A Prospective Multicentre Meta-Epidemiologic Cohort Study.Clinical epidemiology · 2022Article
- Article
- The Potential Role of Extracorporeal Cytokine Removal in Hemodynamic Stabilization in Hyperinflammatory Shock.Biomedicines · 2021Review
- Blood Pressure Reduction in Hypertensive Acute Heart Failure.Current hypertension reports · 2021Review
- Powering Bias and Clinically Important Treatment Effects in Randomized Trials of Critical Illness.Critical care medicine · 2020Article
- Levosimendan Efficacy and Safety: 20 Years of SIMDAX in Clinical Use.Journal of cardiovascular pharmacology · 2020Review
- The attributable mortality of acute respiratory distress syndrome.Intensive care medicine · 2020Article
- Addressing the "What do we have to lose? Just give the drug" rationale: making the case for clinical trials and against off-label use in COVID-19.Journal of thoracic disease · 2020Article
- Focus on clinical trial interpretation.Intensive care medicine · 2020Article
- Levosimendan Efficacy and Safety: 20 years of SIMDAX in Clinical Use.Cardiac failure review · 2020Review
- The management of sepsis: science & fiction.Journal of thoracic disease · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In this paper we discuss the limitations of large randomized controlled trials with mortality endpoints in patients with critical illness associated diagnoses such as sepsis. When patients with the same syndrome diagnosis do not share the pathways that lead to death (the attributable risk), any therapy can only lead to small effects in these populations. Using Monte Carlo simulations, we show how the syndrome-attributable risks of critical illness-associated diagnoses are likely overestimated using common statistical methods. This overestimation of syndrome-attributable risks leads to a corresponding overestimation of attainable treatment effects and an underestimation of required sample sizes. We demonstrate that larger and more 'pragmatic' randomized trials are not the solution because they decrease therapeutic and diagnostic precision, the therapeutic effect size and the probability of finding a beneficial effect. Finally, we argue that the most logical solution is a renewed focus on mechanistic research into the complexities of critical illness syndromes.
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.