Validation of a Novel Frailty Index in Surgical Cohorts

Completed

• Conditions: Surgery--Complications; Perioperative Complication; Anesthesia Morbidity
• Interventions: Other: Frailty risk groups

• Registration Number: NCT03971851
• Lead Sponsor: University of Iceland

Brief Summary

This study will validate the utility of a novel frailty index that uses ICD diagnoses to call frailty severity in a surgical cohort of patients 65 and older

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-01
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Status Verified: 2019-11
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-01
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• Patients 65 years or older, undergoing any surgery at Landspitali University Hospital with an anesthesia team involved

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Exclusion Criteria

• No American Society of Anesthesiology classification provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low frailty	Frailty risk groups	Frailty risk score less than 5
Intermediate Frailty	Frailty risk groups	Frailty risk score 5-15
High frailty	Frailty risk groups	Frailty risk score 15 and above

Primary Outcome Measures

Name	Time	Method
30-day mortality	30-days	Mortality within 30 days of surgery in each of the three frailty risk groups
Time to hospital readmission	Up to 180 days	For patients surviving index hospitalization, the proportional hazard ratio of readmission between the three frailty group

Secondary Outcome Measures

Name	Time	Method
Prolonged hospital length-of stay	3 months	Incidence of patients staying more than 10-days after surgery in the three frailty risk cohorts
Long-term mortality	Up to 14 years	Long-term mortality of the three different frailty risk groups, compared with proportional hazard modeling