Direct Peritoneal Resuscitation Effects in the Damage Control Patient

Not Applicable

Completed

• Conditions: Traumatic Injury
• Interventions: Procedure: Galactose; Procedure: Standard surgical methods

• Registration Number: NCT01771055
• Lead Sponsor: University of Louisville

Brief Summary

The purpose of this study is to find if direct peritoneal resuscitation helps blood flow through important organs in a person's body after they have had a traumatic injury with massive blood loss. Sometimes after severe injuries requiring operation, surgeons cannot close the muscles and skin of a patient's belly, because of swelling. This study will also try to find if direct peritoneal resuscitation decreases tissue swelling and allows for quicker closure of of a patient's belly.

Detailed Description

Standard methods of controlling bleeding and increasing blood flow to vital organs will be used. These methods include giving blood and fluids and surgically repairing the vessels that are causing the bleeding which are standard ways physicians treat injuries with massive blood loss. A drain (a small plastic tube) will be placed inside the belly.

Subjects will randomly (like flipping a coin) be placed into a group of patients who either get a sugar solution dripped into the belly after surgery or do not get this treatment. The drain will be used to drip a high glucose solution into the abdomen in patients be part of that group. The fluid will continue to be dripped into the belly until it is possible to close the skin and underlying layers.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-18
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-05-02
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Results First Posted: 2021-06-16
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• All trauma patients age 18 years or greater with massive blood loss
• Patients requiring a damage control procedure
• Traumatic injury within the last 24 hours

Exclusion Criteria

• Patients who are pregnant
• Less than 18 years of age
• Known chronic renal disease
• Moribund

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Galactose	Galactose	Galactose
Standard resuscitation	Standard surgical methods	Standard surgical methods of controlling bleeding

Primary Outcome Measures

Name	Time	Method
Number of Participants With Morbidity	1 Month	Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.

Trial Locations

Locations (1)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States