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COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
A prospective randomized controlled study of two fluid regimens in the initial management of septic shock in the emergency department.
Pediatric Emergency Care 2008 October
OBJECTIVES: To compare the impact of 40 mL/kg of fluid over 15 minutes followed by dopamine and further titration of therapy to achieve therapeutic goals (study protocol) versus 20 mL/kg over 20 minutes up to a maximum of 60 mL/kg over 1 hour followed by dopamine (control protocol) in septic shock.
DESIGN AND SETTING: Prospective randomized controlled study in the emergency department of a public hospital in India.
PATIENTS: One hundred forty-seven children older than 1 month presenting with septic shock were enrolled into the study.
OUTCOME MEASURES: Hospital mortality (primary outcome), 72-hour survival, achievement of therapeutic goals of shock resolution, incidence of hypoxia, hepatomegaly, intubation at 20, 40, and 60 minutes (secondary outcomes) were compared between the arms.
RESULTS: Seventy-four and 73 children were assigned to the study and control group, respectively. Overall mortality was 17.6%, 26 deaths with 13 in each arm. Mortality in the study cohort was lower than our historical mortality of 50% (P<0.0001), 95% confidence interval (CI), 11.9-24.8. Cumulative survival at 72 hours was 72.5% (95% CI, 58.9-86.1) and 77.6% (95% CI, 66.0%-89.2%) in the control and study groups, respectively. Resolution of shock in the emergency department was associated with survival odds ratio (OR) 9.2 (95% CI, 2.1-40.8). Rapidity of achieving therapeutic goals was not significantly different between groups. Intubation rates were also the same (46.5% in the control group versus 55% in the study group; P=0.28). At 20 minutes, 35.6% of the control group and 70% of the study group had hepatomegaly (P<0.01).
CONCLUSION: There was no difference in the overall mortality, rapidity of shock resolution, or incidence of complications between the groups. The occurrence of hepatomegaly at 20 minutes following 40 mL/kg is of concern in settings with limited access to post-resuscitation ventilator care.
DESIGN AND SETTING: Prospective randomized controlled study in the emergency department of a public hospital in India.
PATIENTS: One hundred forty-seven children older than 1 month presenting with septic shock were enrolled into the study.
OUTCOME MEASURES: Hospital mortality (primary outcome), 72-hour survival, achievement of therapeutic goals of shock resolution, incidence of hypoxia, hepatomegaly, intubation at 20, 40, and 60 minutes (secondary outcomes) were compared between the arms.
RESULTS: Seventy-four and 73 children were assigned to the study and control group, respectively. Overall mortality was 17.6%, 26 deaths with 13 in each arm. Mortality in the study cohort was lower than our historical mortality of 50% (P<0.0001), 95% confidence interval (CI), 11.9-24.8. Cumulative survival at 72 hours was 72.5% (95% CI, 58.9-86.1) and 77.6% (95% CI, 66.0%-89.2%) in the control and study groups, respectively. Resolution of shock in the emergency department was associated with survival odds ratio (OR) 9.2 (95% CI, 2.1-40.8). Rapidity of achieving therapeutic goals was not significantly different between groups. Intubation rates were also the same (46.5% in the control group versus 55% in the study group; P=0.28). At 20 minutes, 35.6% of the control group and 70% of the study group had hepatomegaly (P<0.01).
CONCLUSION: There was no difference in the overall mortality, rapidity of shock resolution, or incidence of complications between the groups. The occurrence of hepatomegaly at 20 minutes following 40 mL/kg is of concern in settings with limited access to post-resuscitation ventilator care.
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