Burn Surgery
Conditions
Brief summary
This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.
Detailed description
This is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients. The groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loss during the surgery.
Interventions
DRUGVasopressin
Vasopressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to arginine vasopressin. It then travels down the axon of that cell, which terminates in the posterior pituitary, and is released from vesicles into the circulation in response to extracellular fluid hypertonicity (hyperosmolality). Arginine vasopressin has two primary functions. First, it increases the amount of solute-free water reabsorbed back into the circulation from the filtrate in the kidney tubules of the nephrons. Second, arginine vasopressin constricts arterioles, which increases peripheral vascular resistance and raises arterial blood pressure.
Sponsors
Asan Medical Center
Hangang Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years old * burn patients undergoing surgery (TBSA \> 20%)
Exclusion criteria
* age \< 18 years old * history of renal disorder * history of cardiac disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | At the end of the surgery, approximately 3 hrs | Comparison of the amounts of estimated blood loss in the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative renal complication | Within 7 postoperative days | Comparison of postoperative acute kidney injury in the two groups. |
| Intraoperative red blood cell transfusion | At the end of the surgery, approximately 3 hrs | Comparison of total units of red blood cell transfusion in the two groups. |
| Postoperative pulmonary complication | Within 7 postoperative days | Comparison of postoperative pulmonary complication in the two groups. |
| Postoperative cardiovascular complication | Within 7 postoperative days | Comparison of postoperative cardiovascular complication in the two groups. |
Countries
South Korea
Contacts
Primary ContactHee Yeong Kim, MD
Outcome results
None listed