Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control

Phase 4

Terminated

• Conditions: Abdominal Injuries
• Interventions: Drug: Sodium Chloride [3%]; Drug: Sodium Chloride [0.9%]

• Registration Number: NCT02542241
• Lead Sponsor: Fundacion Clinica Valle del Lili

Brief 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.

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Study Start: 2015-11-27
• Primary Completion: 2018-09-04
• Study Completion: 2018-09-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Abdominal trauma requiring damage control surgery.
• Acceptance by the patient or by a proxy to be included in the trial.

Exclusion Criteria

• Concomitant severe head trauma, defined by a Glasgow score <9, before receiving sedation or by the presence of cerebral edema or intracranial injury on a CT-scan.
• Pregnancy
• Patient not included 4 hours or more after damage control surgery.
• Damage control laparotomy performed for other indications other than trauma.
• Not index damage control laparotomy
• No acceptance to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride [3%]	Sodium Chloride [3%]	-
Sodium Chloride [0.9%]	Sodium Chloride [0.9%]	-

Primary Outcome Measures

Name	Time	Method
Abdominal wall closure	7 days	Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.

Secondary Outcome Measures

Name	Time	Method
Fluid Balance measured in cm3	72 hours	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.
Incidence of Abdominal compartment syndrome	7 days	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.
Incidence of Organ Failure	7 days	Incidence of organ failure (defined as SOFA score greater than 2).
Mortality	28 days	28 day mortality rate

Trial Locations

Locations (1)

Fundacion Clinica Valle del Lili; 🇨🇴 Cali, Valle Del Cauca, Colombia