Direct Peritoneal Resuscitation Effects in the Damage Control Patient

Traumatic Injury Clinical Trial

Official title:

Direct Peritoneal Resuscitation Effects in the Damage Control Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771055
• Other study ID #: 09.0178
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Traumatic Injury
• Wounds and Injuries

Intervention

Procedure:
• Galactose
Galactose dripped into the abdomen after surgery
• Standard surgical methods

Locations

Country	Name	City	State
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Morbidity	Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.	1 Month