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

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

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.

Study Overview

• Status: Unknown
• Conditions: Burn Surgery
• Intervention / Treatment: Drug: Vasopressin

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 Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Yeong Kim, MD; Phone Number: 82226395650; Email: kimhy@hallym.or.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07247
    • Recruiting
    • Hangang Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.
Experimental: Restrictive group; 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; 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.; 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

Collaborators and Investigators

• Sponsor: Hangang Sacred Heart Hospital
• Collaborators: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2018
• Primary Completion (Anticipated): June 4, 2019
• Study Completion (Anticipated): June 4, 2019

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 8, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 29, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: 2018-051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No