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OpenTrials
Completed

NCT Number: NCT03134807

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

* 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

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General ICU, KSK; Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All admissions in the group

Exclusion criteria

  • None

Treatment and study plan

Observation prospective

Other

No intervention

Other names: Observation and registration of data

Primary outcomes

  1. Survival

    Time frame: 30 days

    ICU and 30 days

  2. Frailty

    Time frame: Pre admission

    Clinical Frailty Scale

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • European Society of Intensive Care Medicine

Registry information

Acronym: VIP1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 1, 2017
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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