Supernormal Oxygen Delivery for Patients With Severe Burns

NCT ID: NCT05241912

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Burn Surgery Dobutamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Dobutamine

Intervention Type DRUG

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

Interventions

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Dobutamine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe burn patients

Exclusion Criteria

* Patients or families refuse to sign consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Red Cross Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liang Bing

Associate senior doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Red cross hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Facility Contacts

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Liang Bing

Role: primary

020-34403854

Other Identifiers

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2022-005-01

Identifier Type: -

Identifier Source: org_study_id

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