Direct Peritoneal Resuscitation Effects in the Damage Control Patient

This study has suspended participant recruitment.
(Need for revised protocol)
Information provided by (Responsible Party):
University of Louisville Identifier:
First received: January 11, 2013
Last updated: June 8, 2015
Last verified: December 2014

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 Intervention Phase
Traumatic Injury
Procedure: Galactose
Procedure: Standard surgical methods
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Direct Peritoneal Resuscitation Effects in the Damage Control Patient

Resource links provided by NLM:

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Evaluate the effect of adjunctive DPR on visceral (liver) organ and systemic perfusion and cellular necrosis in patients in hemorrhagic shock.

Estimated Enrollment: 48
Study Start Date: January 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: University of Louisville Identifier: NCT01771055     History of Changes
Other Study ID Numbers: 09.0178
Study First Received: January 11, 2013
Last Updated: June 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:

Additional relevant MeSH terms:
Wounds and Injuries processed this record on October 06, 2015