SSSP-2
Trial question
What is the effect of an early resuscitation protocol in adults with sepsis and hypotension in resource-limited settings?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 209
209 patients (92 female, 117 male).
Inclusion criteria: adult patients with sepsis and hypotension presenting to the emergency department in resource-limited settings.
Key exclusion criteria: hypoxemia or severe tachypnea; gastrointestinal bleeding in the absence of fever; congestive HF exacerbation; ESRD; elevated jugular venous pressure; incarceration; indications for immediate surgery.
Interventions
N=106 early sepsis protocol (an early aggressive fluid strategy; blood transfusion and titratable dopamine when appropriate).
N=103 usual care (hemodynamic management determined by treating clinicians).
Primary outcome
Death in hospital
48.1%
33%
48.1 %
36.1 %
24.1 %
12.0 %
0.0 %
Early sepsis
protocol
Usual
care
Significant
increase ▲
NNH = 6
Significant increase in death in the hospital (48.1% vs. 33%; RR 1.46, 95% CI 1.04 to 2.05).
Secondary outcomes
Significant increase in IV fluid in the 6 hours after presentation (3.5 L vs. 2 L; AD 1.2 L, 95% CI 1 to 1.5).
Significant increase in vasopressor use (14.2% vs. 1.9%; AD 12.3%, 95% CI 5.1 to 19.4).
Significant increase in death at day 28 (67% vs. 45.3%; RR 1.48, 95% CI 1.14 to 1.91).
Safety outcomes
No significant difference in adverse events.
Significant difference in length of hospital stay (5 days vs. 7 days).
Conclusion
In adult patients with sepsis and hypotension presenting to the emergency department in resource-limited settings, early sepsis protocol was inferior to usual care with respect to death in the hospital.
Reference
Ben Andrews, Matthew W Semler, Levy Muchemwa et al. Effect of an Early Resuscitation Protocol on In-hospital Mortality Among Adults With Sepsis and Hypotension: A Randomized Clinical Trial. JAMA. 2017 Oct 3;318(13):1233-1240.
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