The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients
1 other identifier
interventional
158
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
July 18, 2018
CompletedStudy Start
First participant enrolled
July 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2019
CompletedJuly 31, 2018
July 1, 2018
10 months
June 28, 2018
July 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Intraoperative red blood cell transfusion
At the end of the surgery, approximately 3 hrs
Postoperative pulmonary complication
Within 7 postoperative days
Postoperative cardiovascular complication
Within 7 postoperative days
Postoperative renal complication
Within 7 postoperative days
Study Arms (2)
Control group
NO INTERVENTIONIntraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.
Restrictive group
EXPERIMENTALIntervention: 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- age ≥ 18 years old
- burn patients undergoing surgery (TBSA \> 20%)
You may not qualify if:
- age \< 18 years old
- history of renal disorder
- history of cardiac disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hangang Sacred Heart Hospitallead
- Asan Medical Centercollaborator
Study Sites (1)
Hangang Sacred Heart Hospital
Seoul, 07247, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Kug Kim, MD, PhD
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 28, 2018
First Posted
July 18, 2018
Study Start
July 25, 2018
Primary Completion
June 4, 2019
Study Completion
June 4, 2019
Last Updated
July 31, 2018
Record last verified: 2018-07