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

Fundacion Clinica Valle del Lili

Status and phase

Terminated

Phase 4

Conditions

Abdominal Injuries

Treatments

Drug: Sodium Chloride [3%]

Drug: Sodium Chloride [0.9%]

Study type

Interventional

Funder types

Other

Identifiers

NCT02542241

00877

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.