Intensive Care Unit (ICU) Admission Decisions in the Elde... | NCT00912600

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

NCT00912600

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jul 26, 2012Estimated

Enrollment

2,643Actual

Phase

Not provided

Conditions

Patient Admission
Death
Activities of Daily Living

Interventions

Intensive Care Unit admission

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Jan 2006Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2012

Last Update Posted Date

Jul 26, 2012Estimated

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,643Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Elderly individuals presenting to one of 15 emergency departments and possibly qualifying for admission to an ICU	Other: Intensive Care Unit admission

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensive Care Unit admission	Other	Intensive Care Unit admission	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Hospital death		During the hospitalisation
Change in functional status		During 6 months
Six-month death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bertrand GUIDET, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Saint-Antoine		Paris		75012	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22509296	Derived	Boumendil A, Angus DC, Guitonneau AL, Menn AM, Ginsburg C, Takun K, Davido A, Masmoudi R, Doumenc B, Pateron D, Garrouste-Orgeas M, Somme D, Simon T, Aegerter P, Guidet B; ICE-CUB study group. Variability of intensive care admission decisions for the very elderly. PLoS One. 2012;7(4):e34387. doi: 10.1371/journal.pone.0034387. Epub 2012 Apr 11.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms