Direct Peritoneal Resuscitation Effects in the Damage Control Patient

NCT01771055 | Completed Results

• 1 other identifier: 09.0178
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Injury

Keywords

Trauma; Hypovolemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Morbidity

  Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.

  1 Month

Study Arms (2)

Galactose

EXPERIMENTAL

Galactose

Procedure: Galactose

Standard resuscitation

PLACEBO COMPARATOR

Standard surgical methods of controlling bleeding

Procedure: Standard surgical methods

Interventions

Galactose PROCEDURE

Galactose dripped into the abdomen after surgery

Galactose

Standard surgical methods PROCEDURE

Standard resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are pregnant
• Less than 18 years of age
• Known chronic renal disease
• Moribund

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Hypovolemia

Interventions

Galactose

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Jason Smith
• Organization: University of Louisville

josmit19@louisville.edu

502-852-5675

Study Officials

• Jason Smith, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Galactose versus standard care

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 18, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)