Traumatic Injury
Conditions
Keywords
Trauma, Hypovolemia
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREGalactose
Galactose dripped into the abdomen after surgery
PROCEDUREStandard surgical methods
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Galactose versus standard care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Morbidity | 1 Month | Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Galactose Galactose
Galactose: Galactose dripped into the abdomen after surgery | 3 |
| Standard Resuscitation Standard surgical methods of controlling bleeding
Standard surgical methods | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Galactose | Standard Resuscitation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 3 participants | 4 participants | 7 participants |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Number of Participants With Morbidity
Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.
Time frame: 1 Month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Galactose | Number of Participants With Morbidity | 0 number of participants |
| Standard Resuscitation | Number of Participants With Morbidity | 0 number of participants |