6/29/23, 1:13 AM Rivers Trial Pathway Feedback Search Clinical Topics Home Studies Rivers Trial Rivers Trial Disease Sepsis and septic shock Trial question Is early goal-directed therapy superior to standard therapy in patients with severe sepsis and septic shock? Study design Single center Double blinded RCT Population Characteristics of study participants 49.0% female N = 263 51.0% male 263 patients (130 female, 133 male) Inclusion criteria: patients with severe sepsis and septic shock Key exclusion criteria: age < 18 years, pregnancy, or the presence of an acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, contraindication to central venous catheterization, active gastrointestinal hemorrhage, or seizure Interventions N=130 early goal-directed therapy (according to a protocol for early goal-directed therapy for at least six hours) N=133 standard therapy (as per the protocol for hemodynamic support for at least six hours) https://web.pathway.md/studies/recOwqRBPsGIJB3Ha 1/2 6/29/23, 1:13 AM Rivers Trial Pathway Primary outcome In-hospital death 46.5 % 46.5 34.9 % 30.5 23.3 % Significant decrease 11.6 % NNT = 6 0.0 % Early goal-directed therapy Standard therapy Significant decrease in in-hospital death (30.5% vs. 46.5%; RR 0.58, 95% CI 0.38 to 0.87) Secondary outcomes Significant decrease in mean APACHE II scores (13 vs. 15.9; MD -2.9, 95% CI -4.62 to -1.18) Significant decrease in lactate concentration (3 mmol/L vs. 3.9 mmol/L; MD -0.9, 95% CI -1.66 to -0.14) Significant decrease in base deficit (2 mmol/L vs. 5.1 mmol/L; MD -3.1, 95% CI -5.72 to -0.48) Conclusion In patients with severe sepsis and septic shock, early goal-directed therapy was superior to standard therapy with respect to a in-hospital death. Reference Rivers E, Nguyen B, Havstad S et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. Open reference URL https://web.pathway.md/studies/recOwqRBPsGIJB3Ha 2/2