The Very Old Intensive Care Patient: A Multinational Prospective Observation Study (VIP1)
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|ClinicalTrials.gov Identifier: NCT03134807|
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 15, 2018
- 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
|Condition or disease||Intervention/treatment|
|Critical Illness Old Age; Debility Survival||Other: Observation prospective|
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 Type :||Observational|
|Actual Enrollment :||5132 participants|
|Official Title:||The Very Old Intensive Care Patient: A Multinational Prospective Observation Study|
|Actual Study Start Date :||November 1, 2016|
|Actual Primary Completion Date :||June 15, 2017|
|Actual Study Completion Date :||October 31, 2017|
Admission of elderly ICU patients (≥80)
All consecutibve admission in 3 month period or 20 pateints
Other: Observation prospective
Other Name: Observation and registration of data
- Survival [ Time Frame: 30 days ]ICU and 30 days
- Frailty [ Time Frame: Pre admission ]Clinical Frailty Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134807
|General ICU, KSK; Haukeland University Hospital|
|Bergen, Norway, 5021|
|Principal Investigator:||Hans Flaatten, Prof||University of bergen; ESICM|