Burn SurgeryEarly Phase 1NCT05241912
Supernormal Oxygen Delivery for Patients With Severe Burns
A Early Phase 1 study testing Dobutamine in people with Burn Surgery and Dobutamine, run by Guangzhou Red Cross Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Surgery, Dobutamine
- What is being tested?
- Dobutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2022to 1 Jun 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Severe burn patients
Who cannot join
- Patients or families refuse to sign consent
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Red cross hospital
Guangzhou, Guangdong, 510220
Liang Bing, 020-34403854, 27291375@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Burn Surgery, Dobutamine
- Being tested
- Dobutamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution. |
| Goal-directed fluid group | Experimental | 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. Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
perioperative complications
Measured: One week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start28 Feb 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Bing, Guangzhou Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241912
- Sponsor's protocol ID
- 2022-005-01
- Status last verified
- Jan 2022
- First submitted
- 6 Feb 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supernormal Oxygen Delivery for Patients With Severe Burns：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05241912
- Acronym / sponsor ID
- 2022-005-01
- Conditions
- Burn Surgery, Dobutamine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Red Cross HospitalUniversity, hospital or other
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution. |
| Goal-directed fluid group | Experimental | Drug: DobutamineIntervention: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Severe burn patients
Key exclusion criteria (1 listed)
- Patients or families refuse to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dobutamineadministration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery | Drug | Goal-directed fluid group |
Primary outcome
Complication
Time frame: One week after operation
perioperative complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dobutamine in people with Burn Surgery and Dobutamine, run by Guangzhou Red Cross Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: One week after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.