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Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments

Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01508819
Acronym
ICECUBII
Enrollment
3036
Registered
2012-01-12
Start date
2012-01-31
Completion date
2015-11-30
Last updated
2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Patients Visiting the Emergency Department

Keywords

Patients over 75, acute pathology, ICU admission

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: * 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

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: * 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)

Interventions

OTHERrecommendations 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age over 75 years old * 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

* refusal

Design outcomes

Primary

MeasureTime frame
Mortality six months after emergency department visit6 months after emergency department visit

Secondary

MeasureTime frame
hospital mortalityup to 6 months
ICU admission ratelength of hospital stay
change in functional status6 months after emergency department visit
institutionalization6 months after emergency department visit
quality of life6 months after emergency department visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026