A randomized and controlled trial of the effect of treatment aimed at maximizing oxygen delivery in patients with severe sepsis or septic shock

Objective: To evaluate the effects of increased oxygen delivery on mortalit y and morbidity. Design: Randomized, controlled trial. Setting: Medical-surgical ICU of a tertiary care hospital. Patients: Sixty-three patients classified according to predetermined criter ia as having severe sepsis or septic shock. Interventions: The patients were randomly assigned to one of two groups: th e control group (n = 32) received conventional therapy with a normal target ed value of oxygen delivery, and the treatment group (n = 31) received ther apy with a targeted oxygen delivery index (Do,I) value of > 600 ml/min/m(2) . The therapeutic approach to maintain BP, arterial saturation, hemoglobin concentration, and pulmonary artery occlusion pressure was similar in both groups. Measurements and main results: The hemodynamic, oxygen transport, and gastr ic intramucosal pH measurements were recorded at the time of admission to t he study and every 6 h for the next 96 h. The outcome measures were the rat e of patient mortality and the number of organ dysfunctions occurring durin g the ICU stay. The study groups were similar with respect to demographics and admission he modynamic variables, but the percentage of patients with positive blood cul tures was significantly higher in the control group than in the treatment g roup, respectively: 34 vs 13% (p = 0.04). The average cardiac index was sig nificantly higher in the treatment group than in the control group, respect ively: 3.96 vs 3.05 L/min/m(2) (p = 0.01), This factor did not significantl y affect the Do(2)I. Nine of the 31 treatment group patients reached an ave rage Do,I value of > 600 ml/min/m2, The rate of mortality in the control gr oup patients up to the time of ICU discharge (66%) was similar to that seen in the treatment group (74%), respectively: 21 of 32 vs 23 of 31 (p = 0.46 ). The number of dysfunctional organs per patient was also similar in the c ontrol and treatment groups, respectively: 2.1 +/- 1.1 vs 2.6 +/- 1.2 (p = 0.12). Conclusion: Treatment aimed at maximizing oxygen delivery in patients with severe sepsis or septic shock does not reduce mortality or morbidity.