Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control (CELTA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Abdominal Injuries
• Intervention / Treatment: Drug: Sodium Chloride [3%]; Drug: Sodium Chloride [0.9%]

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia
      • Fundacion Clinica Valle del Lili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium Chloride [3%]	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).; Other Names: NaCl; Hypertonic Saline Solution
Active Comparator: Sodium Chloride [0.9%]	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).; Other Names: Normal Saline; Physiologic Saline Solution

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

Collaborators and Investigators

• Sponsor: Fundacion Clinica Valle del Lili
• Investigators: Principal Investigator: Alberto F García, MD, Fundacion Clinica Valle del Lili

Study record dates

Study Major Dates

• Study Start: November 27, 2015
• Primary Completion (Actual): September 4, 2018
• Study Completion (Actual): September 4, 2018

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: intensive care; Open abdomen; hypertonic saline solution
• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries; Pharmaceutical Solutions
• Other Study ID Numbers: 00877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data contained in the datasets generated and/or analyzed for the current study are not publicly available as recommended by the local ethical and research committee involving human beings (Fundación Valle del Lili, Cali, Colombia) but could be available from the corresponding author on reasonable request and under prior approval by such committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No