Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments (ICECUBII)
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| First Received Date ICMJE | December 9, 2011 | ||||
| Last Updated Date | November 16, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mortality six months after emergency department visit [ Time Frame: 6 months after emergency department visit ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01508819 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments | ||||
| Official Title ICMJE | Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial | ||||
| Brief Summary | Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals. 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:
Primary outcome :Mortality six months after ED visit Secondary outcomes
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| Detailed Description | Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals. 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:
Primary outcome :Mortality six months after ED visit Secondary outcomes
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) |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients over 75 visiting the emergency department with a condition potentially warranting intensive care unit admission |
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| Condition ICMJE | Elderly Patients Visiting the Emergency Department | ||||
| Intervention ICMJE | Other: 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
Other Name: recommendations to admit to ICU all the patients included |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 2992 | ||||
| Estimated Completion Date | June 2015 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 75 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01508819 | ||||
| Other Study ID Numbers ICMJE | K100103 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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