Back to resultsSupernormal Oxygen Delivery for Patients With Severe Burns
Primary Purpose
Burn Surgery, Dobutamine
Status
Not yet recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Dobutamine
Sponsored by
About this trial
This is an interventional prevention trial for Burn Surgery
Eligibility Criteria
Inclusion Criteria:
- Severe burn patients
Exclusion Criteria:
- Patients or families refuse to sign consent
Sites / Locations
- Guangzhou Red cross hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Goal-directed fluid group
Arm Description
Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.
Intervention: 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.
Outcomes
Primary Outcome Measures
Complication
perioperative complications
Secondary Outcome Measures
Full Information
NCT ID
NCT05241912
First Posted
February 6, 2022
Last Updated
February 6, 2022
Sponsor
Guangzhou Red Cross Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05241912
Brief Title
Supernormal Oxygen Delivery for Patients With Severe Burns
Official Title
Supernormal Oxygen Delivery for Patients With Severe Burns：A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Red Cross Hospital
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 goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.
Detailed Description
This is a randomized double-blinded study to investigate the effect of control group and the goal-directed fluid therapy group on complications during surgery of the burn patients. The groups are designated as the control group and the oal-directed fluid therapy group to further evaluate significant differences in complications during the surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Surgery, Dobutamine
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (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
Goal-directed fluid group
Arm Type
Experimental
Arm Description
Intervention: 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.
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery
Primary Outcome Measure Information:
Title
Complication
Description
perioperative complications
Time Frame
One week after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe burn patients
Exclusion Criteria:
Patients or families refuse to sign consent
Facility Information:
Facility Name
Guangzhou Red cross hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510220
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Bing
Phone
020-34403854
Email
27291375@qq.com
12. IPD Sharing Statement
Learn more about this trial
Supernormal Oxygen Delivery for Patients With Severe Burns
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