Supernormal Oxygen Delivery for Patients With Severe Burns
1 other identifier
interventional
100
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 goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Feb 2022
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
February 6, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedStudy Start
First participant enrolled
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedFebruary 16, 2022
January 1, 2022
1.3 years
February 6, 2022
February 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Complication
perioperative complications
One week after operation
Study Arms (2)
Control group
NO INTERVENTIONIntraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.
Goal-directed fluid group
EXPERIMENTALIntervention: administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia. Intraoperative fluid management: administration of 2-4 ml/kg/hr of crystalloid solution.
Interventions
administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery
Eligibility Criteria
You may qualify if:
- Severe burn patients
You may not qualify if:
- Patients or families refuse to sign consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Red cross hospital
Guangzhou, Guangdong, 510220, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- 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
- Associate senior doctor
Study Record Dates
First Submitted
February 6, 2022
First Posted
February 16, 2022
Study Start
February 28, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
February 16, 2022
Record last verified: 2022-01