ProMISe
Trial question
What is the effect of early goal-directed therapy for the resuscitation of patients presenting with early septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 1260
1260 patients (532 female, 728 male).
Inclusion criteria: patients presenting with early septic shock.
Key exclusion criteria: aged < 18 years, known pregnancy, drug overdose, injury from burns or trauma, acute coronary syndrome, requirement for immediate surgery, hemodynamic instability, known history of AIDS, or contraindication to central venous catheterization or blood transfusion.
Interventions
N=630 early goal-directed therapy (target CVP > 8 mmHg, MAP > 65 mmHg, ScvO2 > 70%).
N=630 usual care (decisions at discretion of treating clinician).
Primary outcome
Death at 90 days
29.5%
29.2%
29.5 %
22.1 %
14.8 %
7.4 %
0.0 %
Early goal-directed
therapy
Usual
care
No significant
difference ↔
No significant difference in death at 90 days (29.5% vs. 29.2%; RR 1.01, 95% CI 0.85 to 1.2).
Secondary outcomes
Borderline significant decrease in quality-adjusted life years (4.584 vs. 4.582; ARR 0.002, 95% CI -0.41 to 0.41).
No significant difference in lifetime cost per patient (33620 £ vs. 32142 £; AD 1478 £, 95% CI -1434 to 4390).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients presenting with early septic shock, early goal-directed therapy was not superior to usual care with respect to death at 90 days.
Reference
Mouncey PR, Osborn TM, Power GS et al. Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock. Health Technol Assess. 2015 Nov;19(97):i-xxv, 1-150.
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