Intensive Care Unit (ICU) Admission Decisions in the Elderly : the ICE-CUB Study (IceCub)

July 25, 2012 updated by: Assistance Publique - Hôpitaux de Paris

A Prospective Multicenter Study Examining the Criteria That Determine ICU Admission of Patients Over 80 Who Present to an Emergency Department and Evaluating the Impact of ICU Admission on Short and Mid-term Vital and Functional Outcome

Percentage of patients over 80 admitted in ICU varies greatly from one center to another. ICU admission criteria of older patients are scarcely described and benefit of ICU admission for those patients is uncertain. In this study, we prospectively studied old patients arriving to the emergency department of 15 French hospitals with conditions that potentially warrant ICU admission.The working hypothesis was that ICU admission was associated with a 20% decrease in six-month mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a prospective multicenter observational cohort study of elderly individuals presenting to one of 15 emergency departments and possibly qualifying for admission to an ICU. To be included, subjects had to be aged at least 80 years and be diagnosed by the ED physician with one of 74 conditions potentially warranting ICU admission.Outcome studied are ICU eligibility as assessed by emergency and ICU physicians, hospital and six-month death and changes in functional status in the six month following emergency department visit.

Study Type

Observational

Enrollment (Actual)

2643

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Hôpital Saint-Antoine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Old patients arriving to the emergency department of 15 French hospitals with conditions that potentially warrant ICU admission.

Description

Inclusion Criteria:

  • Age over 80
  • Be assigned by the emergency physician with one of 74 conditions potentially warranting ICU admission

Exclusion Criteria:

  • Patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Elderly individuals presenting to one of 15 emergency departments and possibly qualifying for admission to an ICU
Other: Intensive Care Unit admission
Intensive Care Unit admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ICU eligibility as assessed by emergency and ICU physicians
Time Frame: At the admission
At the admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital death
Time Frame: During the hospitalisation
During the hospitalisation
Change in functional status
Time Frame: During 6 months
During 6 months
Six-month death
Time Frame: During 6 months after the end of the hospitalisation
During 6 months after the end of the hospitalisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Bertrand GUIDET, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

January 1, 2006

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (ESTIMATE)

June 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOR 03 035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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