VIP1: The Very Old Intensive Care Patient: A Multinational Prospective Observation Study

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT03134807
Collaborator
European Society of Intensive Care Medicine (Other)
5,132
1
12
429.1

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Nov 1, 2016
Actual Primary Completion Date :
Jun 15, 2017
Actual Study Completion Date :
Oct 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Admission of elderly ICU patients (≥80)

All consecutibve admission in 3 month period or 20 pateints

Other: Observation prospective
No intervention
Other Names:
  • Observation and registration of data
  • Outcome Measures

    Primary Outcome Measures

    1. Survival [30 days]

      ICU and 30 days

    2. Frailty [Pre admission]

      Clinical Frailty Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    80 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All admissions in the group
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General ICU, KSK; Haukeland University Hospital Bergen Norway 5021

    Sponsors and Collaborators

    • University of Bergen
    • European Society of Intensive Care Medicine

    Investigators

    • Principal Investigator: Hans Flaatten, Prof, University of bergen; ESICM

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hans Flaatten, Professor and senior ICU consultant, University of Bergen
    ClinicalTrials.gov Identifier:
    NCT03134807
    Other Study ID Numbers:
    • ESICM VIP1
    First Posted:
    May 1, 2017
    Last Update Posted:
    May 15, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 15, 2018