Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Primary Purpose
Traumatic Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Galactose
Standard surgical methods
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Injury focused on measuring Trauma, Hypovolemia
Eligibility Criteria
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
Sites / Locations
- University of Louisville Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Galactose
Standard resuscitation
Arm Description
Galactose
Standard surgical methods of controlling bleeding
Outcomes
Primary Outcome Measures
Number of Participants With Morbidity
Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.
Secondary Outcome Measures
Full Information
NCT ID
NCT01771055
First Posted
January 11, 2013
Last Updated
June 15, 2021
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT01771055
Brief Title
Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Official Title
Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Injury
Keywords
Trauma, Hypovolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Galactose versus standard care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Galactose
Arm Type
Experimental
Arm Description
Galactose
Arm Title
Standard resuscitation
Arm Type
Placebo Comparator
Arm Description
Standard surgical methods of controlling bleeding
Intervention Type
Procedure
Intervention Name(s)
Galactose
Intervention Description
Galactose dripped into the abdomen after surgery
Intervention Type
Procedure
Intervention Name(s)
Standard surgical methods
Primary Outcome Measure Information:
Title
Number of Participants With Morbidity
Description
Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Smith, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Direct Peritoneal Resuscitation Effects in the Damage Control Patient
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