Supernormal Oxygen Delivery for Patients With Severe Burns

February 6, 2022 updated by: Liang Bing, Guangzhou Red Cross Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510220
        • Guangzhou Red Cross Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe burn patients

Exclusion Criteria:

  • Patients or families refuse to sign consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: One week after operation
perioperative complications
One week after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Red Cross Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 28, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 6, 2022

First Submitted That Met QC Criteria

February 6, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-005-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burn Surgery

Clinical Trials on Dobutamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe