NCT03134807

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,132 (actual)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Old Age; Debility
• Survival

Interventions

Type	Name	Description
OTHER	Observation prospective	No intervention

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-15
• Completion: 2017-10-31
• First posted: 2017-05-01
• Last updated: 2018-05-15

Locations

1 site across 1 country: Norway