Direct Peritoneal Resuscitation Effects in the Damage Control Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01771055
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : June 8, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Traumatic Injury Procedure: Galactose Procedure: Standard surgical methods Phase 4

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Study Start Date : January 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Morbidity [ Time Frame: 1 Month ]
    Evaluate the effect of adjunctive DPR on visceral (liver) organ and systemic perfusion and cellular necrosis in patients in hemorrhagic shock.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01771055

United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Principal Investigator: Jason Smith, MD University of Louisville

Responsible Party: University of Louisville Identifier: NCT01771055     History of Changes
Other Study ID Numbers: 09.0178
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Louisville:

Additional relevant MeSH terms:
Wounds and Injuries