Direct Peritoneal Resuscitation Effects in the Damage Control Patient

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Louisville
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01771055
First received: January 11, 2013
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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: 46
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Galactose
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01771055

Locations
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jason Smith, MD    502-852-1895    j0smit19@louisville.edu   
Principal Investigator: Jason Smith, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Jason Smith, MD University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01771055     History of Changes
Other Study ID Numbers: 09.0178
Study First Received: January 11, 2013
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Trauma
Hypovolemia

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014