Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control

Abdominal Injuries Clinical Trial

— CELTA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02542241
• Other study ID #: 00877
• Status: Terminated
• Phase: Phase 4
• Start date: November 27, 2015
• Est. completion date: September 4, 2018

Study information

• Verified date: June 2020
• Source: Fundacion Clinica Valle del Lili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: September 4, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Injuries

Intervention

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).
• 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).

Locations

Country	Name	City	State
Colombia	Fundacion Clinica Valle del Lili	Cali	Valle Del Cauca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal wall closure	Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.	7 days
Secondary	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
Secondary	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
Secondary	Incidence of Organ Failure	Incidence of organ failure (defined as SOFA score greater than 2).	7 days
Secondary	Mortality	28 day mortality rate	28 days