The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients

Study Overview
=================
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.

Official Title
-----------------
The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients: a Randomized Clinical Trial

Conditions
-----------------
Burn Surgery

Intervention / Treatment
-----------------
* Drug: Vasopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution. | |
| Experimental: Restrictive group<br>Intervention: administration of vasopressin 0.01 - 0.04 U/min after induction of anesthesia. Intraoperative fluid management: administration of 2-4 ml/kg/hr of crystalloid solution. | Drug: Vasopressin<br>* 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.<br>* Other names: Antidiuretic hormone, arginine vasopressin, or argipressin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | Comparison of the amounts of estimated blood loss in the two groups. | At the end of the surgery, approximately 3 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative red blood cell transfusion | Comparison of total units of red blood cell transfusion in the two groups. | At the end of the surgery, approximately 3 hrs | 
| Postoperative pulmonary complication | Comparison of postoperative pulmonary complication in the two groups. | Within 7 postoperative days | 
| Postoperative cardiovascular complication | Comparison of postoperative cardiovascular complication in the two groups. | Within 7 postoperative days | 
| Postoperative renal complication | Comparison of postoperative acute kidney injury in the two groups. | Within 7 postoperative days |