ArticleBMJ open2023
Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis (RECORDS): study protocol for a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial.
Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04280497 (A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.
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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 Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy and safety of corticosteroids in critically ill patients: a systematic review and meta-analysis.BMC anesthesiology · 2025Pooled it
- Corticosteroids for treating sepsis in children and adults.The Cochrane database of systematic reviews · 2025Pooled it
- Corticosteroids in ARDS: old controversies, new insights, and future directions.Intensive care medicine · 2026Review
- Article
- Artificial Intelligence- and Machine Learning-Assisted Subphenotyping for Personalized Immunotherapy in Sepsis.Journal of personalized medicine · 2026Review
- Is "pre-sepsis" the new sepsis? A narrative review.PLoS pathogens · 2025Review
- Catecholamines in sepsis: pharmacological insights and clinical applications-a narrative review.Journal of anesthesia, analgesia and critical care · 2025Review
- Temporal Transitions of the Hyperinflammatory and Hypoinflammatory Phenotypes in Critical Illness.American journal of respiratory and critical care medicine · 2025Observational
- Reassessing sepsis research: new clues for old players and new players for an old symptom to improve patient outcomes.EXCLI journal · 2025Review
- Causal inference can lead us to modifiable mechanisms and informative archetypes in sepsis.Intensive care medicine · 2024Review
- Towards personalized medicine: a scoping review of immunotherapy in sepsis.Critical care (London, England) · 2024Article
- New clinical trial design in precision medicine: discovery, development and direction.Signal transduction and targeted therapy · 2024Review
- Current perspectives in the management of sepsis and septic shock.Frontiers in medicine · 2024Review
- Extending the 'host response' paradigm from sepsis to cardiogenic shock: evidence, limitations and opportunities.Critical care (London, England) · 2023Review
- Bayesian Sequential Design for Identifying and Ranking Effective Patient Subgroups in Precision Medicine in the Case of Counting Outcome Data with Inflated Zeros.Journal of personalized medicine · 2023Article
Corrections and comments
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Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionCorticosteroids affect variably survival in sepsis trials, suggesting heterogeneity in patients' response to corticosteroids. The RECORDS (Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis) trial aimed at defining endotypes associated with adults with sepsis responsiveness to corticosteroids. METHODS AND ANALYSIS: RECORDS, a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial, will randomly assign to a biomarker stratum 1800 adults with community-acquired pneumonia, vasopressor-dependent sepsis, septic shock or acute respiratory distress syndrome. In each stratum, patients will be randomly assigned to receive a 7-day course of hydrocortisone and fludrocortisone or their placebos. Patients with COVID-19 will be treated with a 10-day standard course of dexamethasone and randomised to fludrocortisone or its placebo. Primary outcome will be 90-day death or persistent organ dysfunction. Large simulation study will be performed across a range of plausible scenarios to foresee power to detect a 5%-10% absolute difference with corticosteroids. We will assess subset-by-treatment interaction by estimating in a Bayesian framework two quantities: (1) measure of influence, relying on the value of the estimation of corticosteroids' effect in each subset, and (2) measure of interaction. ETHICS AND DISSEMINATION: The protocol was approved by the Ethics Committee ( TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04280497).
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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.