Direct Peritoneal Resuscitation Effects in the Damage Control Patient
|Traumatic Injury||Procedure: Galactose Procedure: Standard surgical methods||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Direct Peritoneal Resuscitation Effects in the Damage Control Patient|
- Morbidity [ Time Frame: 1 Month ]Evaluate the effect of adjunctive DPR on visceral (liver) organ and systemic perfusion and cellular necrosis in patients in hemorrhagic shock.
|Study Start Date:||January 2012|
|Study Completion Date:||June 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Galactose dripped into the abdomen after surgery
Placebo Comparator: Standard resuscitation
Standard surgical methods of controlling bleeding
|Procedure: Standard surgical methods|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771055
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Jason Smith, MD||University of Louisville|