Frailty Index and Mortality After a Burn Surgery | NCT05613829

Studies
Frailty Index and Mortality After a Burn Surgery

NCT05613829

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Nov 17, 2022Actual

Enrollment

1,118Actual

Phase

Not provided

Conditions

Burns
Frailty

Interventions

Burn surgery

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Aug 31, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Nov 7, 2022

First Posted Date

Nov 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2022

Last Update Posted Date

Nov 17, 2022Actual

Name	Class
Hangang Sacred Heart Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Frailty is a condition of a reduced physiological reserve and is associated with postoperative morbidity and mortality. We evaluated the impact of preoperative frailty index (CFI) on 90-day mortality after a burn surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with burn injury			Other: Burn surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Burn surgery	Other	Patients underwent burn surgery	patients with burn injury

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality after burn surgery	Postoperative 90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with burn injuries were admitted to the burn ICU.

Exclusion Criteria:

Patients with incomplete medical records were excluded.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients aged ≥ 18 years who were admitted to the burn ICU from 2012 to 2021.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young Joo Seo	Hangang Sacred Heart Hospital	Principal Investigator
Young-Kug Kim	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan medical Center		Seoul		05505	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D000073496	Frailty

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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