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

This study has been completed.
Sponsor:
Collaborators:
University Hospital of Ferrara
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Maurizia Capuzzo, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01422070
First received: August 19, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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. The LOIS will be used as a surrogate of ICU costs.
  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.

Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • Hospital mortality of the patients admitted to the participating study Units. [ Time Frame: Max 90 days after admission to the Study Unit ] [ Designated as safety issue: No ]
    Vital status at hospital discharge


Secondary Outcome Measures:
  • Lengths of ICU Stay (LOIS) [ Time Frame: Max 90 days after admission to the Study Unit ] [ Designated as safety issue: No ]
    Number of days (calendar days -1) from admission to and discharge from the Study Unit

  • Lengths of Hospital Stay (LOHS) [ Time Frame: Max 90 days after admission to the Study Unit ] [ Designated as safety issue: No ]
    Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital

  • Number of ICU readmissions [ Time Frame: Max 90 days after admission to the Study Unit ] [ Designated as safety issue: No ]
    Number of patients readmitted to the Study Unit during the same hospital course


Enrollment: 6433
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients admitted to the Study Units
Consecutive adult patients consecutively admitted to the Study Units during one month (either from 7th November to 4th December 2010, or from 16th January to 12th February 2012)

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.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All adult patients consecutively admitted to the Study Units during one month (from 7th November to 4th December 2010)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422070

Locations
Italy
Maurizia Capuzzo
Ferrara, Italy, 44121
Sponsors and Collaborators
Università degli Studi di Ferrara
University Hospital of Ferrara
European Society of Intensive Care Medicine
Investigators
Principal Investigator: Maurizia Capuzzo, MD Azienda Ospedaliero-Universitaria di Ferrara, Italy
Study Chair: Christophe Combescure, Statistician University of Geneva, Switzerland
Study Chair: Bertrand Guidet, PhD Hôpital Saint-Antoine, Paris, France
Study Chair: Gaetano Iapichino, MD Hospital San Paolo, University of Milan, Italy
Study Chair: Paolo Merlani, MD University of Geneva, Switzerland
Study Chair: Rui P Moreno, PhD Hospital de Santo Antonio dos Capuchos, Lisbon, Portugal
Study Chair: Thomas Perneger, Statistician University of Geneva, Switzerland
Study Chair: Andrew Rhodes, PhD St George's Hospital, London, UK
Study Chair: Andreas Valentin, MD University of Vienna, Austria
  More Information

No publications provided

Responsible Party: Maurizia Capuzzo, Medical Doctor, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT01422070     History of Changes
Other Study ID Numbers: 80-2011
Study First Received: August 19, 2011
Last Updated: February 17, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
mortality
intensive care
critical care
intermediate care

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014