CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6,433 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01422070
NCT01422070N/ACompleted

A Multi-centre European Observational Study to Assess Whether Patients Admitted to the ICUs With Availability of Intermediate Care Unit (IMCU) Have Lower Hospital Mortality Than Those Admitted to the ICUs Without Availability of IMCU

Università degli Studi di Ferrara·observational·Posted Aug 23, 2011·Updated Aug 21, 2015

In Brief

An observational study for Critical Illness. Completed, enrolled 6,433 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.9 years ago