Direct Peritoneal Resuscitation Effects in the Damage Control Patient

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Injury
• Intervention / Treatment: Procedure: Galactose; Procedure: Standard surgical methods

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Galactose	Procedure: Galactose; Galactose dripped into the abdomen after surgery
Placebo Comparator: Standard resuscitation; Standard surgical methods of controlling bleeding	Procedure: Standard surgical methods

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Jason Smith, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 17, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Trauma; Hypovolemia
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 09.0178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No