BACKGROUND: We previously found that regardless of the animal injury model used resuscitation strategies that minimize fluid administration requirements lead to better outcomes. We hypothesized that a resuscitation regimen that limited the total volume of fluid administered would reduce morbidity and mortality rates in critically ill trauma patients. METHODS: We performed a double-blind randomized trial to assess the safety and efficacy of adding vasopressin to resuscitative fluid. Subjects were hypotensive adults who had sustained acute traumatic injury. Subjects were given fluid alone (control group) or fluid plus vasopressin (experimental group), first as a bolus (4 IU) and then as an intravenous infusion of 200 ml/h (vasopressin 2.4 IU/h) for 5 h. RESULTS: We randomly assigned 78 patients to the experimental group (n=38) or the control group (n=40). The groups were similar in age, sex, preexisting medical illnesses, and mechanism and severity of injury. Serum vasopressin concentrations were higher in the experimental group than in the control group at admission, after infusion of vasopressin (p=0.01), and 12 h later. The experimental group required a significantly lower total volume of resuscitation fluid over 5 days than did the control group (p=0.04). The mortality rate at 5 days was 13% in the experimental group and 25% in the control group (p=0.19). The rates of adverse events, organ dysfunction, and 30-day mortality were similar. CONCLUSIONS: This is the first trial to investigate the impact of vasopressin administration in trauma patients. Infusion of low-dose vasopressin maintained elevated serum vasopressin levels and decreased fluid requirements after injury.
RCT Entities:
BACKGROUND: We previously found that regardless of the animal injury model used resuscitation strategies that minimize fluid administration requirements lead to better outcomes. We hypothesized that a resuscitation regimen that limited the total volume of fluid administered would reduce morbidity and mortality rates in critically ill traumapatients. METHODS: We performed a double-blind randomized trial to assess the safety and efficacy of adding vasopressin to resuscitative fluid. Subjects were hypotensive adults who had sustained acute traumatic injury. Subjects were given fluid alone (control group) or fluid plus vasopressin (experimental group), first as a bolus (4 IU) and then as an intravenous infusion of 200 ml/h (vasopressin 2.4 IU/h) for 5 h. RESULTS: We randomly assigned 78 patients to the experimental group (n=38) or the control group (n=40). The groups were similar in age, sex, preexisting medical illnesses, and mechanism and severity of injury. Serum vasopressin concentrations were higher in the experimental group than in the control group at admission, after infusion of vasopressin (p=0.01), and 12 h later. The experimental group required a significantly lower total volume of resuscitation fluid over 5 days than did the control group (p=0.04). The mortality rate at 5 days was 13% in the experimental group and 25% in the control group (p=0.19). The rates of adverse events, organ dysfunction, and 30-day mortality were similar. CONCLUSIONS: This is the first trial to investigate the impact of vasopressin administration in traumapatients. Infusion of low-dose vasopressin maintained elevated serum vasopressin levels and decreased fluid requirements after injury.
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