Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: a stepped wedge cluster randomized clinical trial
An erratum to this article was published (Intensive Care Med, Oct 2024 ↗)
Authors' conclusion
Among 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.
Study context
- Population
- Adult emergency department (ED) patients with suspected sepsis (Sepsis-3 criteria, quick sequential organ failure assessment (SOFA) score ≥ 2 or lactate > 2 mmol/L)analysed
- Participants
- 872 patients
- Comparison
- Implementation of the 1-h sepsis bundle vs control
- Interventionn = 387
- Controln = 485reference
- Primary endpoint
- In-hospital mortality truncated at 28 days
- Follow-up
- 28 days
Methodological detailspragmatic, cluster-randomized, multicentre (23 EDs, France and Spain), Study period ended after 873 patients were included (1148 planned)
- Pragmatic
- Cluster-randomized
- Multicentre (23 EDs, France and Spain)
- Study period ended after 873 patients were included (1148 planned)
Primary result
As reported in the abstract
In-hospital mortality
Each group vs controlAdjusted relative risk (95% CI)
Intervention
0.81(0.48–1.39)
- Intervention
- difference in percentage - 0.4 (95% CI - 5.1 to 4.2)
Secondary outcomes
Time to antibiotic administration
difference (min) - 73 (- 93 to - 53)
Fluid resuscitation within 3 h
- Significantly higher rate, volume and shorter time to fluid resuscitation in the intervention group
Other secondary endpoints (incl. acute HF at 24 h, SOFA at 72 h, intensive care unit (ICU) LOS, ventilation/RRT days, vasopressor-free days, unnecessary antibiotics, 28-day mortality)
- No differences between groups
Original publication
Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: a stepped wedge cluster randomized clinical trial. Intensive Care Med. Published 24 June 2024. doi:10.
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