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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
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Hans Flaatten, 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

Condition or disease Intervention/treatment
Critical Illness Old Age; Debility Survival Other: Observation prospective

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.


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Study Type : Observational
Actual Enrollment : 5132 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Admission of elderly ICU patients (≥80)
All consecutibve admission in 3 month period or 20 pateints
Other: Observation prospective
No intervention
Other Name: Observation and registration of data




Primary Outcome Measures :
  1. Survival [ Time Frame: 30 days ]
    ICU and 30 days

  2. Frailty [ Time Frame: Pre admission ]
    Clinical Frailty Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critical ill elderly patients admitted to an ICU
Criteria

Inclusion Criteria:

  • All admissions in the group

Exclusion Criteria:


Information from the National Library of Medicine

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


Locations
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Norway
General ICU, KSK; Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
University of Bergen
European Society of Intensive Care Medicine
Investigators
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Principal Investigator: Hans Flaatten, Prof University of bergen; ESICM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hans Flaatten, Professor and senior ICU consultant, University of Bergen
ClinicalTrials.gov Identifier: NCT03134807     History of Changes
Other Study ID Numbers: ESICM VIP1
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes