Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution and Severe Burn Injury

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients younger than 18 years old.
• Patients with severe cardiopulmonary diseases, or associated with other major trauma.
• Patient with incomplete data.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.; 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient mortality	The primary outcome was patient mortality after major burn.	Up to 6 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 202101364B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No