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

Burn Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03590873
• Other study ID #: 2018-051
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: June 4, 2019

Study information

• Verified date: July 2018
• Source: Hangang Sacred Heart Hospital
• Contact: Hee Yeong Kim, MD
• Phone: 82226395650
• Email: kimhy[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Surgery
• Burns

Intervention

Drug:
• Vasopressin
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.

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative pulmonary complication	Comparison of postoperative pulmonary complication in the two groups.	Within 7 postoperative days
Secondary	Postoperative cardiovascular complication	Comparison of postoperative cardiovascular complication in the two groups.	Within 7 postoperative days
Secondary	Postoperative renal complication	Comparison of postoperative acute kidney injury in the two groups.	Within 7 postoperative days