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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 26, 2017
First Posted Date May 1, 2017
Last Update Posted Date May 15, 2018
Actual Study Start Date November 1, 2016
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2017)
  • Survival [ Time Frame: 30 days ]
    ICU and 30 days
  • Frailty [ Time Frame: Pre admission ]
    Clinical Frailty Scale
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Very Old Intensive Care Patient: A Multinational Prospective Observation Study
Official Title The Very Old Intensive Care Patient: A Multinational Prospective Observation Study
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Critical ill elderly patients admitted to an ICU
Condition
  • Critical Illness
  • Old Age; Debility
  • Survival
Intervention Other: Observation prospective
No intervention
Other Name: Observation and registration of data
Study Groups/Cohorts Admission of elderly ICU patients (≥80)
All consecutibve admission in 3 month period or 20 pateints
Intervention: Other: Observation prospective
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2018)
5132
Original Estimated Enrollment
 (submitted: April 26, 2017)
2000
Actual Study Completion Date October 31, 2017
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All admissions in the group

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 80 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03134807
Other Study ID Numbers ESICM VIP1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Hans Flaatten, University of Bergen
Original Responsible Party Same as current
Current Study Sponsor University of Bergen
Original Study Sponsor Same as current
Collaborators European Society of Intensive Care Medicine
Investigators
Principal Investigator: Hans Flaatten, Prof University of bergen; ESICM
PRS Account University of Bergen
Verification Date May 2018