Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control

Study Overview
=================
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.

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

Conditions
-----------------
Abdominal Injuries

Intervention / Treatment
-----------------
* Drug: Sodium Chloride [3%]
* Drug: Sodium Chloride [0.9%]


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Chloride [3%]<br> | Drug: Sodium Chloride [3%]<br>* 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).<br>* Other names: NaCl;|
| Active Comparator: Sodium Chloride [0.9%]<br> | Drug: Sodium Chloride [0.9%]<br>* 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).<br>* Other names: Normal Saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal wall closure | Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 7 days | 
| Incidence of Organ Failure | Incidence of organ failure (defined as SOFA score greater than 2). | 7 days | 
| Mortality | 28 day mortality rate | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open abdomen, hypertonic saline solution, intensive care