Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution and Severe Burn Injury
1 other identifier
observational
66
1 country
1
Brief Summary
This study aimed to optimize fluid resuscitation with transpulmonary thermodilution (TPTD)-guided protocol and to lower the mortality rate of the severely burned.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedFirst Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedJune 15, 2022
June 1, 2022
4 months
June 7, 2022
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Patient mortality
The primary outcome was patient mortality after major burn.
Up to 6 months
Study Arms (1)
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.
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients younger than 18 years old.
- Patients with severe cardiopulmonary diseases, or associated with other major trauma.
- Patient with incomplete data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 15, 2022
Study Start
August 7, 2021
Primary Completion
November 30, 2021
Study Completion
January 20, 2022
Last Updated
June 15, 2022
Record last verified: 2022-06