6/29/23, 1:45 AM ProMISe Pathway Feedback Search Clinical Topics Home Studies ProMISe ProMISe Disease Sepsis and septic shock 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 42.4% female N = 1260 57.6% male 1260 patients (528 female, 723 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 https://web.pathway.md/studies/reciEVlP2zmmPNHJC 1/2 6/29/23, 1:45 AM ProMISe Pathway Death at 90 days 29.5 % 29.5 29.2 22.1 % 14.8 % 7.4 % No significant difference 0.0 % Early goal-directed therapy Usual care 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. Open reference URL https://web.pathway.md/studies/reciEVlP2zmmPNHJC 2/2