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

Not Applicable

• Conditions: Burn Surgery
• Interventions: Drug: Vasopressin

• Registration Number: NCT03590873
• Lead Sponsor: Hangang Sacred Heart Hospital

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.

Study Timeline

• Study First Submitted: 2018-06-28
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-08
• Study First Posted: 2018-07-18
• Study Start: 2018-07-25
• Last Update Submitted: 2018-07-29
• Last Update Posted: 2018-07-31
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive group	Vasopressin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative pulmonary complication	Within 7 postoperative days	Comparison of postoperative pulmonary complication 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 cardiovascular complication	Within 7 postoperative days	Comparison of postoperative cardiovascular complication in the two groups.
Postoperative renal complication	Within 7 postoperative days	Comparison of postoperative acute kidney injury in the two groups.

Trial Locations

Locations (1)

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of