NCT02542241

Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control

Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Fundacion Clinica Valle del Lili · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Abdominal Injuries

Interventions

Type	Name	Description
DRUG	Sodium Chloride [3%]	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).
DRUG	Sodium Chloride [0.9%]	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).

Timeline

• Start date: 2015-11-27
• Primary completion: 2018-09-04
• Completion: 2018-09-04
• First posted: 2015-09-04
• Last updated: 2020-06-11

Locations

1 site across 1 country: Colombia