Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments
NCT ID: NCT01508819
Last Updated: 2016-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3036 participants
OBSERVATIONAL
2012-01-31
2015-11-30
Brief Summary
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The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study.
Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted.
Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit.
Secondary objective : Assess the impact of the strategy on:
* In-hospital mortality
* Rate of ICU admission
* Place of living and quality of life six months after ED visit
Primary outcome :Mortality six months after ED visit Secondary outcomes
* In-hospital mortality
* ICU admission
* Change in functional status six months after ED visit
* institutionalization
* Quality of life six months after ED visit
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Detailed Description
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The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study.
Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted.
Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit.
Secondary objective : Assess the impact of the strategy on:
* In-hospital mortality
* Rate of ICU admission
* Place of living and quality of life six months after ED visit
Primary outcome :Mortality six months after ED visit Secondary outcomes
* In-hospital mortality
* ICU admission
* Change in functional status six months after ED visit
* institutionalization
* Quality of life six months after ED visit
Type of study Cluster stratified randomized controlled trial. Stratification criteria are existence of an acute geriatric ward, capacity of the emergency department and location of the hospital (in or out Paris area)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Guidelines for ICU admission of elderly patients arriving in Emergency Departments with a life threatening conditions
recommendations to admit to ICU all the patients included
recommendations to emergency and ICU physicians to admit to ICU all the patients included in the trial
2
no intervention
No interventions assigned to this group
Interventions
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recommendations to admit to ICU all the patients included
recommendations to emergency and ICU physicians to admit to ICU all the patients included in the trial
Eligibility Criteria
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Inclusion Criteria
* At least one organ failure
* No cachexia
* No active known cancer
* Good functional status (as assessed by an ADL score \> 4) or not evaluable
* Affiliated to social security
Exclusion Criteria
75 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Bertrand Guidet, PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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ICU - Saint-Antoine Hospital
Paris, , France
Countries
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References
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Guidet B, Leblanc G, Simon T, Woimant M, Quenot JP, Ganansia O, Maignan M, Yordanov Y, Delerme S, Doumenc B, Fartoukh M, Charestan P, Trognon P, Galichon B, Javaud N, Patzak A, Garrouste-Orgeas M, Thomas C, Azerad S, Pateron D, Boumendil A; ICE-CUB 2 Study Network. Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1450-1459. doi: 10.1001/jama.2017.13889.
Boumendil A, Woimant M, Quenot JP, Rooryck FX, Makhlouf F, Yordanov Y, Delerme S, Takun K, Ray P, Kouka MC, Poly C, Garrouste-Orgeas M, Thomas C, Simon T, Azerad S, Leblanc G, Pateron D, Guidet B; ICE-CUB 2 study network. Designing and conducting a cluster-randomized trial of ICU admission for the elderly patients: the ICE-CUB 2 study. Ann Intensive Care. 2016 Dec;6(1):74. doi: 10.1186/s13613-016-0161-5. Epub 2016 Jul 29.
Other Identifiers
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K100103
Identifier Type: -
Identifier Source: org_study_id
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