Validation of a Novel Frailty Index in Surgical Cohorts

Surgery--Complications Clinical Trial

Official title:

Testing and Validation of a Novel Frailty Index in a Surgical Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971851
• Other study ID #: FrailtyAndSurgery
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2019
• Source: University of Iceland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50000
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No American Society of Anesthesiology classification provided

Related Conditions & MeSH terms

• Anesthesia Morbidity
• Frailty
• Perioperative Complication
• Surgery--Complications

Intervention

Other:
• Frailty risk groups
Patients older than 65 will be separated into groups of varying frailty risk

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Iceland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	Mortality within 30 days of surgery in each of the three frailty risk groups	30-days
Primary	Time to hospital readmission	For patients surviving index hospitalization, the proportional hazard ratio of readmission between the three frailty group	Up to 180 days
Secondary	Long-term mortality	Long-term mortality of the three different frailty risk groups, compared with proportional hazard modeling	Up to 14 years
Secondary	Prolonged hospital length-of stay	Incidence of patients staying more than 10-days after surgery in the three frailty risk cohorts	3 months