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Direct Peritoneal Resuscitation Effects in the Damage Control Patient

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Completed

Conditions

Traumatic Injury

Treatments

Procedure: Galactose
Procedure: Standard surgical methods

Study type

Interventional

Funder types

Other

Identifiers

NCT01771055
09.0178

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups, including a placebo group

Galactose
Experimental group
Description:
Galactose
Treatment:
Procedure: Galactose
Standard resuscitation
Placebo Comparator group
Description:
Standard surgical methods of controlling bleeding
Treatment:
Procedure: Standard surgical methods

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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