This study aimed to determine whether hypertonic saline solution is effective in the resuscitation of injured patients undergoing abdominal damage control surgery regarding early closure of the abdominal wall.
A double-blind, controlled, randomized clinical trial was conducted to determine the impact of an infusion of hypertonic saline 3% vs. isotonic saline 0.9% at a dose of 50 mL/hr for the first 72 hours in patients with abdominal trauma requiring damage control surgery regarding some clinically relevant outcomes. These outcomes were: The timing of abdominal cavity closure, fluids balance, abdominal hypertension, and abdominal compartment syndrome occurrence, organ dysfunction, and 28 days' mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Patients in this arm will receive an intravenous infusion of 3% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).
Patients in this arm will receive an intravenous infusion of 0.9% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).
Fundacion Clinica Valle del Lili
Cali, Valle del Cauca Department, Colombia
Abdominal wall closure
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
Time frame: 7 days
Fluid Balance measured in cm3
Fluid balance during the first 72 hours after injury. Defined as the difference between the amount of fluids taken into the body and the amount excreted or lost. Input includes oral fluids, infused intravenous fluids and blood products. Output includes fluid loss as urine, emesis and wound drainage among others.
Time frame: 72 hours
Incidence of Abdominal compartment syndrome
Incidence of abdominal compartment syndrome (defined as sustained intra-abdominal pressure \> 20 mmHg, accompanied by new organ dysfunction, defined as a score \> 2, under the SOFA scale compromising lung, kidney, or heart) during the first 7 days after injury.
Time frame: 7 days
Incidence of Organ Failure
Incidence of organ failure (defined as SOFA score greater than 2).
Time frame: 7 days
Mortality
28 day mortality rate
Time frame: 28 days
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