Direct Peritoneal Resuscitation Effects in the Damage Control Patient

Study Overview
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Brief Summary
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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
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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.

Official Title
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Direct Peritoneal Resuscitation Effects in the Damage Control Patient

Conditions
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Traumatic Injury

Intervention / Treatment
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* Procedure: Galactose
* Procedure: Standard surgical methods


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Galactose versus standard care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galactose<br>Galactose | Procedure: Galactose<br>* Galactose dripped into the abdomen after surgery<br>|
| Placebo Comparator: Standard resuscitation<br>Standard surgical methods of controlling bleeding | Procedure: Standard surgical methods<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Morbidity | Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care. | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Hypovolemia