NCT05420610

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

June 7, 2022

Last Update Submit

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.

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.

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.

Patients with major burn.

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.

Patients with major burn.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

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

Locations