Trial reportIntensive care medicine2024
Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: a stepped wedge cluster randomized clinical trial.
Trial report in Intensive care medicine, 2024. 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 22 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Effect of Severe Sepsis and Septic Shock Management Bundle (SEP-1) Compliance and Implementation on Mortality Among Patients With Sepsis : A Systematic Review.Annals of internal medicine · 2025Pooled it
- Recent advances in screening, diagnosis, prognosis and personalized treatment of sepsis.European journal of microbiology & immunology · 2026Review
- Presenting Symptoms and Antibiotic Timing Among Hospitalized Adults With Presumed Sepsis.JAMA network open · 2026Article
- Hour-1 Sepsis Bundle: Updated Evidence.Journal of clinical medicine · 2026Review
- Clinical Outcomes for Emergency Department Presentations of Sepsis Managed on a Clinical Pathway: A Systematic Review and Meta-Analysis.Healthcare (Basel, Switzerland) · 2026Review
- Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock 2026.Intensive care medicine · 2026Article
- Completion of the 1-Hour Sepsis Bundle on 90-Day Mortality in Adult Patients With Sepsis.Journal of the American College of Emergency Physicians open · 2026Article
- External validation of SOFA 2 score: a retrospective Chinese cohort study.Annals of intensive care · 2026Article
- Diagnostic Accuracy of Simplified Prehospital Sepsis Screening Tools for Identifying Sepsis and Predicting 30-Day Mortality: A Retrospective Diagnostic Accuracy Study.Clinical epidemiology · 2026Article
- Early Prediction of In-Hospital Mortality in Patients with Acute Infections: Development of the Acute Severity Infection Score (ASIs).Infectious diseases and therapy · 2025Article
- Mortality and antibiotic timing in deep learning-derived surviving sepsis campaign risk groups: a multicenter study.Critical care (London, England) · 2025Observational
- Antibiotics for suspected sepsis: who and when?Intensive care medicine · 2025Article
- Article
- Article
- Development and validation of a nomogram for predicting in-hospital mortality in older adult hip fracture patients with atrial fibrillation: a retrospective study.Frontiers in medicine · 2025Article
- A Rare Case of Yersinia Pseudotuberculosis Infection with Septic Shock and Splenic Infarction.Infection and drug resistance · 2025Article
- SHKBP1 is a target for sepsis: evidence from WGCNA and multiple machine learning algorithms.Frontiers in immunology · 2025Article
- Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: faster is better for the sicker ones!Intensive care medicine · 2024Article
- Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: faster is better for the sicker ones! Author's reply.Intensive care medicine · 2024Article
- Clinical impact of the implementation of monocyte distribution width (MDW) measurement on time to anti-infective administration in sepsis patients in the emergency department: a before/after cohort study.Critical care (London, England) · 2024Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
28 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe efficacy of the 1-h bundle for emergency department (ED) patients with suspected sepsis, which includes lactate measurement, blood culture, broad-spectrum antibiotics administration, administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥ 4 mmol/L, remains controversial.
methodsWe carried out a pragmatic stepped-wedge cluster-randomized trial in 23 EDs in France and Spain. Adult patients with Sepsis-3 criteria or a quick sequential organ failure assessment (SOFA) score ≥ 2 or a lactate > 2 mmol/L were eligible. The intervention was the implementation of the 1-h sepsis bundle. The primary outcome was in-hospital mortality truncated at 28 days. Secondary outcomes included volume of fluid resuscitation at 24 h, acute heart failure at 24 h, SOFA score at 72 h, intensive care unit (ICU) length of stay, number of days on mechanical ventilation or renal replacement therapy, vasopressor free days, unnecessary antibiotic administration, and mortality at 28 days. 1148 patients were planned to be analysed; the study period ended after 873 patients were included.
results872 patients (mean age 66, 42% female) were analyzed: 387 (44.4%) in the intervention group and 485 (55.6%) in the control group. Median SOFA score was 3 [1-5]. Median time to antibiotic administration was 40 min in the intervention group vs 113 min in the control group (difference - 73 [95% confidence interval (CI) - 93 to - 53]). There was a significantly higher rate, volume, and shorter time to fluid resuscitation within 3 h in the intervention group. There were 47 (12.1%) in-hospital deaths in the intervention group compared to 61 (12.6%) in the control group (difference in percentage - 0.4 [95% CI - 5.1 to 4.2], adjusted relative risk (aRR) 0.81 [95% CI 0.48 to 1.39]). There were no differences between groups for other secondary endpoints.
conclusionsAmong patients with suspected sepsis in the ED, the implementation of the 1-h sepsis bundle was not associated with significant difference in in-hospital mortality. However, this study may be underpowered to report a statistically significant difference between groups.
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