BurnsNCT05420610
Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution and Severe Burn Injury
An observational study of Burns, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aimed to optimize fluid resuscitation with transpulmonary thermodilution (TPTD)-guided protocol and to lower the mortality rate of the severely burned. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Burns
- What is being tested?
- Study group: TPTD device was implemented for monitoring.
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Aug 2021to 20 Jan 2022
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2011 to June 2019, all adult patients (age > 18 years) suffered from major burn,23 defined as total burned surface area (TBSA) > 20% with at least second degree burn depth were admitted to the intensive care unit (ICU) of the Burn Center at a tertiary medical center were retrospectively reviewed.
Who may be able to join
- Adult patients (age > 18 years).
- Major burn (as total burned surface area (TBSA) > 20% with at least second degree burn depth).
- Admitted to the intensive care unit (ICU) of the Burn Center.
Who cannot join
- Patients younger than 18 years old.
- Patients with severe cardiopulmonary diseases, or associated with other major trauma.
- Patient with incomplete data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution for Treating Adult Patients With Severe Burn Injury
This study aimed to optimize fluid resuscitation with transpulmonary thermodilution (TPTD)-guided protocol and to lower the mortality rate of the severely burned.
- Conditions
- Burns
- Being tested
- Control group: Patients being admitted when The advancement of transpulmonary thermodilution(TPTD) device was unavailable., Study group: TPTD device was implemented for monitoring.
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group: Patients being admitted when The advancement of transpulmonary thermodilution(TPTD) device was unavailable.Other
The control group included patients being admitted when TPTD device was unavailable; and relatively stable patients without the need for TPTD. The adequacy of fluid resuscitation in the control group was monitored by traditional monitoring parameters including vital signs and hourly urine output.
Study group: TPTD device was implemented for monitoring.Other
TPTD device was implemented for monitoring; the inclusion criteria included patients suffering from 2nd degree burn greater than 40% TBSA; a combined 2nd to 3rd degree burn greater than 30% TBSA; or patients with inhalation injury despite the burned surface area.
| Study group | Role | What they receive |
|---|---|---|
| Patients with major burn. | Adult patients (age > 18 years) suffered from major burn which defined as total burned surface area (TBSA) > 20% with at least second degree burn depth were admitted to the intensive care unit (ICU) of the Burn Center at a tertiary medical center were retrospectively reviewed. Receives: Other: Control group: Patients being admitted when The advancement of transpulmonary thermodilution(TPTD) device was unavailable.; Other: Study group: TPTD device was implemented for monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient mortality
The primary outcome was patient mortality after major burn.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start7 Aug 2021
- Primary completion30 Nov 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420610
- Sponsor's protocol ID
- 202101364B0
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 15 Jun 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 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution for Treating Adult Patients With Severe Burn Injury
- ClinicalTrials.gov ID
- NCT05420610
- Acronym / sponsor ID
- 202101364B0
- Conditions
- Burns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 15 Jun 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 study aimed to optimize fluid resuscitation with transpulmonary thermodilution (TPTD)-guided protocol and to lower the mortality rate of the severely burned.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with major burn. | – | Other: Control group: Patients being admitted when The advancement of transpulmonary thermodilution(TPTD) device was unavailable., Other: Study group: TPTD device was implemented for monitoring.Adult patients (age > 18 years) suffered from major burn which defined as total burned surface area (TBSA) > 20% with at least second degree burn depth were admitted to the intensive care unit (ICU) of the Burn Center at a tertiary medical center were retrospectively reviewed. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2011 to June 2019, all adult patients (age > 18 years) suffered from major burn,23 defined as total burned surface area (TBSA) > 20% with at least second degree burn depth were admitted to the intensive care unit (ICU) of the Burn Center at a tertiary medical center were retrospectively reviewed.
Key inclusion criteria (3 listed)
- Adult patients (age > 18 years).
- Major burn (as total burned surface area (TBSA) > 20% with at least second degree burn depth).
- Admitted to the intensive care unit (ICU) of the Burn Center.
Key exclusion criteria (3 listed)
- Patients younger than 18 years old.
- Patients with severe cardiopulmonary diseases, or associated with other major trauma.
- Patient with incomplete data.
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 |
|---|---|---|
| Control group: Patients being admitted when The advancement of transpulmonary thermodilution(TPTD) device was unavailable.The control group included patients being admitted when TPTD device was unavailable; and relatively stable patients without the need for TPTD. The adequacy of fluid resuscitation in the control group was monitored by traditional monitoring parameters including vital signs and hourly urine output. | Other | Patients with major burn. |
| Study group: TPTD device was implemented for monitoring.TPTD device was implemented for monitoring; the inclusion criteria included patients suffering from 2nd degree burn greater than 40% TBSA; a combined 2nd to 3rd degree burn greater than 30% TBSA; or patients with inhalation injury despite the burned surface area. | Other | Patients with major burn. |
Primary outcome
Patient mortality
Time frame: Up to 6 months
The primary outcome was patient mortality after major burn.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jun 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient mortality (time frame: Up to 6 months). 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 15 Jun 2022.