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

Critical Illness Clinical Trial

— VIP1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134807
• Other study ID #: ESICM VIP1
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2018
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5132
• Est. completion date: October 31, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• All admissions in the group

Exclusion Criteria:

Related Conditions & MeSH terms

• Critical Illness
• Old Age; Debility
• Survival

Intervention

Other:
• Observation prospective
No intervention

Locations

Country	Name	City	State
Norway	General ICU, KSK; Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	European Society of Intensive Care Medicine

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	ICU and 30 days	30 days
Primary	Frailty	Clinical Frailty Scale	Pre admission

External Links

•   Official study home page