NCT03971851

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
14.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2019

Enrollment Period

15.2 years

First QC Date

May 31, 2019

Last Update Submit

November 3, 2020

Conditions

Surgery--ComplicationsAnesthesia MorbidityPerioperative Complication

Outcome Measures

Primary Outcomes (2)

  • 30-day mortality

    Mortality within 30 days of surgery in each of the three frailty risk groups

    30-days

  • 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 Outcomes (2)

  • Long-term mortality

    Up to 14 years

  • Prolonged hospital length-of stay

    3 months

Study Arms (3)

Low frailty

Frailty risk score less than 5

Other: Frailty risk groups

Intermediate Frailty

Frailty risk score 5-15

Other: Frailty risk groups

High frailty

Frailty risk score 15 and above

Other: Frailty risk groups

Interventions

Frailty risk groupsOTHER

Patients older than 65 will be separated into groups of varying frailty risk

High frailtyIntermediate FrailtyLow frailty

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals over 65 years of age undergoing surgery at a University Hospital Setting

You may qualify if:

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

You may not qualify if:

  • No American Society of Anesthesiology classification provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Martin I Sigurdsson, MD, PhD

    University of Iceland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 3, 2019

Study Start

January 1, 2005

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

November 4, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Just summary data will be shared