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

Primary Purpose

Burn Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vasopressin
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burn Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hangang Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Restrictive group

Arm Description

Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.

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.

Outcomes

Primary Outcome Measures

Intraoperative blood loss
Comparison of the amounts of estimated blood loss in the two groups.

Secondary Outcome Measures

Intraoperative red blood cell transfusion
Comparison of total units of red blood cell transfusion in the two groups.
Postoperative pulmonary complication
Comparison of postoperative pulmonary complication in the two groups.
Postoperative cardiovascular complication
Comparison of postoperative cardiovascular complication in the two groups.
Postoperative renal complication
Comparison of postoperative acute kidney injury in the two groups.

Full Information

First Posted
June 28, 2018
Last Updated
July 29, 2018
Sponsor
Hangang Sacred Heart Hospital
Collaborators
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03590873
Brief Title
The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients
Official Title
The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
June 4, 2019 (Anticipated)
Study Completion Date
June 4, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.
Arm Title
Restrictive group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Other Intervention Name(s)
Antidiuretic hormone, arginine vasopressin, or argipressin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Comparison of the amounts of estimated blood loss in the two groups.
Time Frame
At the end of the surgery, approximately 3 hrs
Secondary Outcome Measure Information:
Title
Intraoperative red blood cell transfusion
Description
Comparison of total units of red blood cell transfusion in the two groups.
Time Frame
At the end of the surgery, approximately 3 hrs
Title
Postoperative pulmonary complication
Description
Comparison of postoperative pulmonary complication in the two groups.
Time Frame
Within 7 postoperative days
Title
Postoperative cardiovascular complication
Description
Comparison of postoperative cardiovascular complication in the two groups.
Time Frame
Within 7 postoperative days
Title
Postoperative renal complication
Description
Comparison of postoperative acute kidney injury in the two groups.
Time Frame
Within 7 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Yeong Kim, MD
Phone
82226395650
Email
kimhy@hallym.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Yeong Kim, MD

12. IPD Sharing Statement

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

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