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

NCT01422070 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6433

Last updated 2015-08-21

Study results available
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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.

Conditions

  • Critical Illness

Sponsors & Collaborators

  • University Hospital of Ferrara

    collaborator OTHER
  • European Society of Intensive Care Medicine

    collaborator OTHER
  • Università degli Studi di Ferrara

    lead OTHER

Principal Investigators

  • Maurizia Capuzzo, MD · Azienda Ospedaliero-Universitaria di Ferrara, Italy

  • Christophe Combescure, Statistician · University of Geneva, Switzerland

  • Bertrand Guidet, PhD · Hôpital Saint-Antoine, Paris, France

  • Gaetano Iapichino, MD · Hospital San Paolo, University of Milan, Italy

  • Paolo Merlani, MD · University of Geneva, Switzerland

  • Rui P Moreno, PhD · Hospital de Santo Antonio dos Capuchos, Lisbon, Portugal

  • Thomas Perneger, Statistician · University of Geneva, Switzerland

  • Andrew Rhodes, PhD · St George's Hospital, London, UK

  • Andreas Valentin, MD · University of Vienna, Austria

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422070 on ClinicalTrials.gov