Patient AdmissionIceCubNCT00912600
Intensive Care Unit (ICU) Admission Decisions in the Elderly : the ICE-CUB Study
An observational study of Patient Admission and Death, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Patient Admission, Death, Activities of Daily Living
- What is being tested?
- Intensive Care Unit admission
- How many people
- 2,643 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2004to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Old patients arriving to the emergency department of 15 French hospitals with conditions that potentially warrant ICU admission.
Who may be able to join
- Age over 80
- Be assigned by the emergency physician with one of 74 conditions potentially warranting ICU admission
Who cannot join
- Patient's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Admission, Death, Activities of Daily Living
- Being tested
- Intensive Care Unit admission
- Keywords
- Intensive Care Units, Triage, Aged, 80 and over, Death, Activities of Daily Living, Health Services Research, Health Care Quality, Access, and Evaluation
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Care Unit admissionOther
Intensive Care Unit admission
| Study group | Role | What they receive |
|---|---|---|
| 1 | Elderly individuals presenting to one of 15 emergency departments and possibly qualifying for admission to an ICU Receives: Other: Intensive Care Unit admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU eligibility as assessed by emergency and ICU physicians
Measured: At the admission
Secondary outcomes (3)
Hospital death
Measured: During the hospitalisation
Change in functional status
Measured: During 6 months
Six-month death
Measured: During 6 months after the end of the hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startNov 2004
- Primary completionJan 2006
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient AdmissionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand GUIDET, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912600
- Sponsor's protocol ID
- AOR 03 035
- Acronym
- IceCub
- Status last verified
- May 2009
- First submitted
- 2 Jun 2009
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22509296
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00912600
- Acronym / sponsor ID
- IceCub / AOR 03 035
- Conditions
- Patient Admission, Death, Activities of Daily Living
- Keywords
- Intensive Care Units, Triage, Aged, 80 and over, Death, Activities of Daily Living, Health Services Research, Health Care Quality, Access, and Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,643 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Intensive Care Unit admissionElderly individuals presenting to one of 15 emergency departments and possibly qualifying for admission to an ICU |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Old patients arriving to the emergency department of 15 French hospitals with conditions that potentially warrant ICU admission.
Key inclusion criteria (2 listed)
- Age over 80
- Be assigned by the emergency physician with one of 74 conditions potentially warranting ICU admission
Key exclusion criteria (1 listed)
- Patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Care Unit admissionIntensive Care Unit admission | Other | 1 |
Primary outcome
ICU eligibility as assessed by emergency and ICU physicians
Time frame: At the admission
3 secondary outcomes
Hospital death
Time frame: During the hospitalisation
Change in functional status
Time frame: During 6 months
Six-month death
Time frame: During 6 months after the end of the hospitalisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
- Derived from this study: PubMed 22509296Boumendil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand GUIDET, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Admission and Death, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU eligibility as assessed by emergency and ICU physicians (time frame: At the admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.