OBJECTIVE: To evaluate the effects of increased oxygen delivery on mortality and morbidity. DESIGN: Randomized, controlled trial. SETTING: Medical-surgical ICU of a tertiary care hospital. PATIENTS: Sixty-three patients classified according to predetermined criteria as having severe sepsis or septic shock. INTERVENTIONS: The patients were randomly assigned to one of two groups: the control group (n = 32) received conventional therapy with a normal targeted value of oxygen delivery, and the treatment group (n = 31) received therapy with a targeted oxygen delivery index (DO2I) value of > 600 mL/min/m2. 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 gastric intramucosal pH measurements were recorded at the time of admission to the study and every 6 h for the next 96 h. The outcome measures were the rate of patient mortality and the number of organ dysfunctions occurring during the ICU stay. The study groups were similar with respect to demographics and admission hemodynamic variables, but the percentage of patients with positive blood cultures was significantly higher in the control group than in the treatment group, respectively: 34 vs 13% (p = 0.04). The average cardiac index was significantly higher in the treatment group than in the control group, respectively: 3.96 vs 3.05 L/min/m2 (p = 0.01). This factor did not significantly affect the DO2I. Nine of the 31 treatment group patients reached an average DO2I value of > 600 mL/min/m2. The rate of mortality in the control group 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 control 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.
RCT Entities:
OBJECTIVE: To evaluate the effects of increased oxygen delivery on mortality and morbidity. DESIGN: Randomized, controlled trial. SETTING: Medical-surgical ICU of a tertiary care hospital. PATIENTS: Sixty-three patients classified according to predetermined criteria as having severe sepsis or septic shock. INTERVENTIONS: The patients were randomly assigned to one of two groups: the control group (n = 32) received conventional therapy with a normal targeted value of oxygen delivery, and the treatment group (n = 31) received therapy with a targeted oxygen delivery index (DO2I) value of > 600 mL/min/m2. 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 gastric intramucosal pH measurements were recorded at the time of admission to the study and every 6 h for the next 96 h. The outcome measures were the rate of patient mortality and the number of organ dysfunctions occurring during the ICU stay. The study groups were similar with respect to demographics and admission hemodynamic variables, but the percentage of patients with positive blood cultures was significantly higher in the control group than in the treatment group, respectively: 34 vs 13% (p = 0.04). The average cardiac index was significantly higher in the treatment group than in the control group, respectively: 3.96 vs 3.05 L/min/m2 (p = 0.01). This factor did not significantly affect the DO2I. Nine of the 31 treatment group patients reached an average DO2I value of > 600 mL/min/m2. The rate of mortality in the control group 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 control 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.
Authors: Massimo Antonelli; Mitchell Levy; Peter J D Andrews; Jean Chastre; Leonard D Hudson; Constantine Manthous; G Umberto Meduri; Rui P Moreno; Christian Putensen; Thomas Stewart; Antoni Torres Journal: Intensive Care Med Date: 2007-04 Impact factor: 17.440
Authors: Alan E Jones; Michael D Brown; Stephen Trzeciak; Nathan I Shapiro; John S Garrett; Alan C Heffner; Jeffrey A Kline Journal: Crit Care Med Date: 2008-10 Impact factor: 7.598
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