Direct Peritoneal Resuscitation Effects in the Damage Control Patient
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|ClinicalTrials.gov Identifier: NCT01771055|
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Injury||Procedure: Galactose Procedure: Standard surgical methods||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Direct Peritoneal Resuscitation Effects in the Damage Control Patient|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Galactose dripped into the abdomen after surgery
Placebo Comparator: Standard resuscitation
Standard surgical methods of controlling bleeding
Procedure: Standard surgical methods
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771055
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Jason Smith, MD||University of Louisville|