Elderly Patients Visiting the Emergency Department Clinical Trial
— ICECUBIIOfficial title:
Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial
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
| Status | Completed |
| Enrollment | 3036 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 75 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | ICU - Saint-Antoine Hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality six months after emergency department visit | 6 months after emergency department visit | Yes | |
| Secondary | hospital mortality | up to 6 months | Yes | |
| Secondary | ICU admission rate | length of hospital stay | No | |
| Secondary | change in functional status | 6 months after emergency department visit | No | |
| Secondary | institutionalization | 6 months after emergency department visit | No | |
| Secondary | quality of life | 6 months after emergency department visit | No |