Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-27

Study Completion Date

2018-09-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abdominal Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium Chloride [3%]

Group Type EXPERIMENTAL

Sodium Chloride [3%]

Intervention Type DRUG

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%]

Group Type ACTIVE_COMPARATOR

Sodium Chloride [0.9%]

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Hypertonic Saline Solution NaCl Physiologic Saline Solution Normal Saline

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No