Rivers Trial
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
51.0% male
N = 263
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).
Primary outcome
In-hospital death
30.5%
46.5%
46.5 %
34.9 %
23.3 %
11.6 %
0.0 %
Early goal-directed
therapy
Standard
therapy
Significant
decrease ▼
NNT = 6
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 points vs. 15.9 points; 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
E Rivers, B Nguyen, S Havstad 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.
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