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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galactose | Experimental | Galactose |
|
| Standard resuscitation | Placebo Comparator | Standard surgical methods of controlling bleeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galactose | Procedure | Galactose dripped into the abdomen after surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Morbidity | Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care. | 1 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Smith, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard of care without peritoneal resuscitation |
| FG001 | Direct Peritoneal Resuscitation | Subjects received standard operation plus direct peritoneal resuscitation after surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Galactose | Galactose Galactose: Galactose dripped into the abdomen after surgery |
| BG001 | Standard Resuscitation | Standard surgical methods of controlling bleeding Standard surgical methods |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Morbidity | Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care. | Posted | Number | number of participants | 1 Month |
|
30 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galactose | Galactose Galactose: Galactose dripped into the abdomen after surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Smith | University of Louisville | 502-852-5675 | josmit19@louisville.edu |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020896 | Hypovolemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005690 | Galactose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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Galactose versus standard care
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| Standard surgical methods |
| Procedure |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Standard Resuscitation | Standard surgical methods of controlling bleeding Standard surgical methods | 0 | 4 | 0 | 4 | 0 | 4 |
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