N/A
N=5,834
European Mortality & Length Of Intensive Care Unit (ICU) Stay Evaluation (ELOISE)
Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT01422070 ↗Enrolled (actual)
5,834
Serious AEs
—
Results posted
Mar 2015
Primary outcome: Primary: Vital Status at Hospital Discharge — 1232; 165 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Università degli Studi di Ferrara
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vital Status at Hospital Discharge |
1232; 165 | — |
| SECONDARY Length of ICU Stay |
3.7; 2.8 | — |
| SECONDARY Length of Hospital Stay |
13.9; 11.0 | — |
| SECONDARY Number of ICU Readmissions |
292; 40 | <0.05 sig |
Summary
The starting point of ELOISE is the significant number of Intensive Care Unit (ICU) survivors who die after the transfer to ward. This mortality rate nullifies the sophisticated diagnostics and the life-support therapies adopted in the ICU.
The inadequate care available at the destination ward has been suggested as one of the reasons to explain the bad outcome of some ICU survivors, but most hospitals do not have enough ICU beds to prolong the ICU stay until the patient has fully recovered. Therefore, Inter Mediate Care Units (IMCU) with levels of nursing staff and costs lower than ICU but higher than wards have been proposed to facilitate discharges of ICU patients. Unfortunately the literature does provide evidence of efficacy of IMCU.
The primary aim of the study is to assess whether the patients admitted to ICUs with availability of IMCU have lower hospital mortality than those admitted to the ICU without availability of IMCU.
Secondary aims are as follows:
1. To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients admitted to ICUs with or without availability of IMCU.
2. To assess the influence of IMCU on the rate of ICU readmissions.
3. To compare the hospital survival of patients discharged to IMCU and general ward (in hospital with or without availability of IMCU) adjusted for severity of illness and nursing workload at ICU discharge. This last aim will require a larger sample size (more than 10,000), but we hope to collect such a sample.
Eligibility Criteria
Inclusion Criteria
- admission to one of the Study Unit
- any organ support allowed
- age of at least 16 years
Exclusion Criteria
- age lower than 16 years
- patients admitted as donor for transplant
- patients admitted with limitation of care stated before admission
Data sourced from ClinicalTrials.gov (NCT01422070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.