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

Critical Illness Clinical Trial

— ELOISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422070
• Other study ID #: 80-2011
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: July 31, 2015
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2015
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6433
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Italy	Maurizia Capuzzo	Ferrara

Sponsors (3)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara	European Society of Intensive Care Medicine, University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Capuzzo M, Volta C, Tassinati T, Moreno R, Valentin A, Guidet B, Iapichino G, Martin C, Perneger T, Combescure C, Poncet A, Rhodes A; Working Group on Health Economics of the European Society of Intensive Care Medicine. Hospital mortality of adults admitt — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Max 90 days after admission to the Study Unit	No
Secondary	Length of ICU Stay	Number of days (calendar days -1) from admission to and discharge from the Study Unit	Max 90 days after admission to intensive care unit	No
Secondary	Length of Hospital Stay	Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital	Max 90 days after admission to the Study Unit	No
Secondary	Number of ICU Readmissions	Number of readmissions to intensive care unit during the same hospital course	Max 90 days after admission to the Study Unit	No

External Links

•   web site for the ELOISE study