Supernormal Oxygen Delivery for Patients With Severe Burns

Sponsor

Guangzhou Red Cross Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05241912

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burn Surgery Dobutamine	Drug: Dobutamine	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Supernormal Oxygen Delivery for Patients With Severe Burns：A Randomized Controlled Trial

Anticipated Study Start Date :

Feb 28, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.
Experimental: Goal-directed fluid group 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.	Drug: Dobutamine administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery

Arm

Intervention/Treatment

No Intervention: Control group

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

Experimental: Goal-directed fluid group

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.

Drug: Dobutamine

administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery

Outcome Measures

Primary Outcome Measures

Complication [One week after operation]
perioperative complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Severe burn patients

Exclusion Criteria:

Patients or families refuse to sign consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Red cross hospital	Guangzhou	Guangdong	China	510220

Sponsors and Collaborators

Guangzhou Red Cross Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liang Bing, Associate senior doctor, Guangzhou Red Cross Hospital

ClinicalTrials.gov Identifier:

NCT05241912

Other Study ID Numbers:

2022-005-01

First Posted:

Feb 16, 2022

Last Update Posted:

Feb 16, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Burns

Dobutamine

Study Results

No Results Posted as of Feb 16, 2022