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Completed

NCT Number: NCT01771055

Direct Peritoneal Resuscitation Effects in the Damage Control Patient

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.

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Key information

Conditions

Traumatic Injury Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Galactose

Procedure

Galactose dripped into the abdomen after surgery

Standard surgical methods

Procedure

Primary outcomes

  1. Number of Participants With Morbidity

    Time frame: 1 Month

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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2013
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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