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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00912600
Other study ID # AOR 03 035
Secondary ID
Status Completed
Phase N/A
First received June 2, 2009
Last updated July 25, 2012
Start date November 2004
Est. completion date February 2009

Study information

Verified date May 2009
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection Authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2643
Est. completion date February 2009
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 80 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Intensive Care Unit admission
Intensive Care Unit admission

Locations

Country Name City State
France Hôpital Saint-Antoine Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary ICU eligibility as assessed by emergency and ICU physicians At the admission No
Secondary Hospital death During the hospitalisation Yes
Secondary Change in functional status During 6 months No
Secondary Six-month death During 6 months after the end of the hospitalisation Yes
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