1-Hour Bundle in Sepsis
Trial question
What is the effect of 1-hour sepsis bundle in patients with suspected sepsis in the emergency department?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 872
872 patients (362 female, 510 male).
Inclusion criteria: patients with suspected sepsis in the emergency department.
Key exclusion criteria: acute HF; living in assisted-living residential homes or palliative centers; estimated life expectancy of < 3 months; pregnancy/lactation; incarceration.
Interventions
N=387 1-hour sepsis bundle (lactate measurement, blood culture, broad-spectrum antibiotics administration, administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥ 4 mmol/L).
N=485 standard care (receipt of care as per the treating emergency physician's routine practice).
Primary outcome
Death in hospital at day 28
12.1%
12.6%
12.6 %
9.4 %
6.3 %
3.1 %
0.0 %
1-hour sepsis
bundle
Standard
care
No significant
difference ↔
No significant difference in death in the hospital at day 28 (12.1% vs. 12.6%; RR 0.81, 95% CI 0.48 to 1.39).
Secondary outcomes
No significant difference in mean fluid resuscitation in the first 24 hour (2000 mL vs. 1600 mL; RR 1.13, 95% CI 0.95 to 1.35).
No significant difference in acute HF within 24 hours (2.4% vs. 3.5%; RR 0.85, 95% CI 0.23 to 3.11).
No significant difference in median SOFA score at 72 hours (2 vs. 1; RR 1.19, 95% CI 0.83 to 1.71).
Conclusion
In patients with suspected sepsis in the emergency department, 1-hour sepsis bundle was not superior to standard care with respect to death in the hospital at day 28.
Reference
Yonathan Freund, Marta Cancella de Abreu, Soufiane Lebal et al. 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. 2024 Jul;50(7):1086-1095.
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