The Very Old Intensive Care Patient: A Multinational Prospective Observation Study

Completed

• Conditions: Survival; Critical Illness; Old Age; Debility
• Interventions: Other: Observation prospective

• Registration Number: NCT03134807
• Lead Sponsor: University of Bergen

Brief Summary

* The primary aim is to document the incidence and short-term outcome of the elderly ICU patient (≥ 80 years) using a multicentre, multi national approach

* The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group

* To create hypothesis for further studies, in particular on various outcome prediction

Detailed Description

The investigators have chosen to use a prospective registration of routinely collected data in this ICU population. The study is mainly European based, but will also allow for ICUs outside Europe to participate.

20 consecutive ICU admission in patients ≥ 80 years of age will be collected OR all patients ≥ 80 years in a three months' period (whatever comes first).

Data are collected electronically through an e-CRF and with baseline documentation of the ICU. The database is located in Denmark, at the Department of Epidemiology, University of Aarhus (http://vip1study.com/) . Each ICU will only have access through the database of their own patients, and patient ID is not registered (Names, birth-date or social security numbers) so it is in that sense anonymous.

Even with de-identified data, most countries must seek necessary consent from the authorities to collect such data, and hence there will be a period between ICU recruitment (starting April 2016) and patient recruitment (October 1. 2016) to allow for this to be done prior to study start.

The goal is to recruit at least 100 ICUs which will give data from approximately 2000 elderly patients.

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Primary Completion: 2017-06-15
• Study Completion: 2017-10-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-11
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5132

Inclusion Criteria

• All admissions in the group

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Admission of elderly ICU patients (≥80)	Observation prospective	All consecutibve admission in 3 month period or 20 pateints

Primary Outcome Measures

Name	Time	Method
Survival	30 days	ICU and 30 days
Frailty	Pre admission	Clinical Frailty Scale

Trial Locations

Locations (1)

General ICU, KSK; Haukeland University Hospital; 🇳🇴 Bergen, Norway