Skip to content

European Mortality & Length Of Intensive Care Unit (ICU) Stay Evaluation (ELOISE)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01422070
Acronym
ELOISE
Enrollment
6433
Registered
2011-08-23
Start date
2011-11-30
Completion date
2012-06-30
Last updated
2015-08-21

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

Conditions

Critical Illness

Keywords

mortality, intensive care, critical care, intermediate care

Brief 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.

Detailed description

Despite the high cost of Intensive Care Unit (ICU), a significant number of patients surviving intensive care die subsequently in hospital after the transfer to ward. Mortality rates after discharge from ICU have been reported to range from 6.1 to 27% In 2000, it was reported that premature discharge from ICU was more likely to occur at night and was associated with higher death rates. Suggested factors that might account for a worse outcome for night discharges were poorer quantity and quality of care available at night both during transfer and at the destination. The implication of this study for the health system was that many hospitals did not have enough ICU beds. To facilitate earlier ICU discharges of ICU patients who are thought to need more care than those which can be provided on wards, InterMediate Care Units (IMCU) with level of nursing staff (and costs) lower than ICU were proposed more than a decade ago. Despite the relevance of the topic, the literature on the efficacy and cost-effectiveness of IMCU available at present shows variable results. And the potential benefits of IMCUs remain uncertain. The most striking are probably the following questions: * Does IMCU decrease the hospital mortality rate of ICU patients? * Does IMCU allow earlier ICU discharge and hence improve patients flux through the ICU and reduce ICU cost? * Does IMCU permit a reduction of ICU readmissions? We propose to address these issues in a large multinational, multicentre study.

Interventions

None listed

Sponsors

University Hospital of Ferrara
CollaboratorOTHER
European Society of Intensive Care Medicine
CollaboratorOTHER
Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Vital Status at Hospital DischargeMax 90 days after admission to the Study UnitHospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital

Secondary

MeasureTime frameDescription
Length of ICU StayMax 90 days after admission to intensive care unitNumber of days (calendar days -1) from admission to and discharge from the Study Unit
Length of Hospital StayMax 90 days after admission to the Study UnitNumber of days (calendar days -1) from admission to the Study Unit to discharge from the hospital
Number of ICU ReadmissionsMax 90 days after admission to the Study UnitNumber of readmissions to intensive care unit during the same hospital course

Countries

Italy

Participant flow

Recruitment details

All admissions of patients aged ≥ 16 years to a study during 28-day period (from 7 Nov to 4 Dec 2011, or from 16 Jan to 12 Feb 2012), excludind admissions only for organ donation, and with any limitation of care stated before unit admission. Maximum number of admissions per unit was 100.

Pre-assignment details

Prospective observational study, without group assignment. Study units gave information about organization. 32 admissions to units with level of care lower than intensive care unit (ICU), 337 readmissions, 83 admissions out of the dates of enrollment slots, and 147 admissions with unknown vital status at hospital discharge were excluded.

Participants by arm

ArmCount
Units With Intermediate Care Unit
Patients admitted to intensive care unit with intermediate care unit in the hospital
5,031
Units Without Intermediate Care Unit
Patients admitted to intensive care unit without intermediate care unit in the hospital
803
Total5,834

Baseline characteristics

CharacteristicUnits With Intermediate Care UnitUnits Without Intermediate Care UnitTotal
Age, Continuous65 years68 years65 years
Sex: Female, Male
Female
2002 Participants332 Participants2334 Participants
Sex: Female, Male
Male
3029 Participants471 Participants3500 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Vital Status at Hospital Discharge

Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital

Time frame: Max 90 days after admission to the Study Unit

ArmMeasureValue (NUMBER)
Units in Hospitals With Intermediate Care UnitVital Status at Hospital Discharge1232 participants
Units in Hospitals Without Intermediate Care UnitVital Status at Hospital Discharge165 participants
Secondary

Length of Hospital Stay

Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital

Time frame: Max 90 days after admission to the Study Unit

ArmMeasureValue (MEDIAN)
Units in Hospitals With Intermediate Care UnitLength of Hospital Stay13.9 days
Units in Hospitals Without Intermediate Care UnitLength of Hospital Stay11.0 days
Secondary

Length of ICU Stay

Number of days (calendar days -1) from admission to and discharge from the Study Unit

Time frame: Max 90 days after admission to intensive care unit

ArmMeasureValue (MEDIAN)
Units in Hospitals With Intermediate Care UnitLength of ICU Stay3.7 days
Units in Hospitals Without Intermediate Care UnitLength of ICU Stay2.8 days
Secondary

Number of ICU Readmissions

Number of readmissions to intensive care unit during the same hospital course

Time frame: Max 90 days after admission to the Study Unit

ArmMeasureValue (NUMBER)
Units in Hospitals With Intermediate Care UnitNumber of ICU Readmissions292 readmissions
Units in Hospitals Without Intermediate Care UnitNumber of ICU Readmissions40 readmissions
Comparison: The null hypothesis was that hospital mortality of patients admitted to intensive care units with intermediate care unit in the hospital is similar to that of the patients admitted to intensive care units without intermediate care unit in the hospitalp-value: <0.0595% CI: [0.45, 0.88]generalized estimating equation

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026