The effect of an early resuscitation protocol on sepsis outcomes in developing countries remains unknown.OBJECTIVE To determine whether an early resuscitation protocol with administration of intravenous fluids, vasopressors, and blood transfusion decreases mortality among Zambian adults with sepsis and hypotension compared with usual care. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 212 adults with sepsis (suspected infection plus Ն2 systemic inflammatory response syndrome criteria) and hypotension (systolic blood pressure Յ90 mm Hg or mean arterial pressure Յ65 mm Hg) presenting to the emergency department at a 1500-bed referral hospital in Zambia between
Objective To assess the efficacy of a simple, goal-directed sepsis treatment protocol for reducing mortality in patients with severe sepsis in Zambia. Design Single center non-blinded randomized controlled trial Setting Emergency room, ICU, and medical wards of the national referral hospital in Lusaka, Zambia Patients 112 patients enrolled within 24 hours of admission with severe sepsis, defined as systemic inflammatory response syndrome with suspected infection and organ dysfunction Interventions Simplified Severe Sepsis Protocol (SSSP) consisting of up to 4 liters of intravenous fluids within 6 hours, guided by jugular venous pressure assessment, and dopamine and/or blood transfusion in selected patients. Control group was managed as usual care. Blood cultures were collected and early antibiotics administered for both arms. Measurements and Main Results Primary outcome was in-hospital all-cause mortality. 109 patients were included in the final analysis. 88 (80.7%) were HIV positive. Pulmonary infections were the most common source of sepsis. In-hospital mortality rate was 64.2% in the intervention group and 60.7% in the control group (RR 1.05, 95%CI:0.79-1.41). Mycobacterium tuberculosis complex was isolated from 31 of 82 (37.8%) HIV positive patients with available mycobacterial blood culture results. SSSP patients received significantly more IV fluids in the first 6 hours (2.7 liters vs. 1.7 liters, p=0.002). The study was stopped early because of high mortality rate among patients with hypoxemic respiratory failure in the intervention arm (8/8, 100%) compared with the control arm [7/10, 70%, RR 1.43 (95%CI:0.95-2.14)]. Conclusion Factors other than tissue hypoperfusion probably account for much of the end organ dysfunction in African patients with severe sepsis. Studies of fluid-based interventions should utilize inclusion criteria to accurately capture patients with hypovolemia and tissue hypoperfusion who are most likely to benefit from fluids. Exclusion of patients with severe respiratory distress should be considered when ventilator support is not readily available.
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