Clinical trial NCT01422070: European Mortality & Length Of Intensive Care Unit (ICU) Stay Evaluation (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: mortality
intensive care
critical care
intermediate care
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: University Hospital of Ferrara
name: European Society of Intensive Care Medicine
First posted: 2011-08-23
Enrollment: 6433
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility 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

Primary outcomes:
measure: Vital Status at Hospital Discharge
timeFrame: Max 90 days after admission to the Study Unit
Secondary outcomes:
measure: Length of ICU Stay
timeFrame: Max 90 days after admission to intensive care unit
measure: Length of Hospital Stay
timeFrame: Max 90 days after admission to the Study Unit
measure: Number of ICU Readmissions
timeFrame: Max 90 days after admission to the Study Unit
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Maurizia Capuzzo
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Ferrara, Italy
name: Maurizia Capuzzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Geneva, Switzerland
name: Christophe Combescure, Statistician
role: STUDY_CHAIR
affiliation: Hôpital Saint-Antoine, Paris, France
name: Bertrand Guidet, PhD
role: STUDY_CHAIR
affiliation: Hospital San Paolo, University of Milan, Italy
name: Gaetano Iapichino, MD
role: STUDY_CHAIR
affiliation: University of Geneva, Switzerland
name: Paolo Merlani, MD
role: STUDY_CHAIR
affiliation: Hospital de Santo Antonio dos Capuchos, Lisbon, Portugal
name: Rui P Moreno, PhD
role: STUDY_CHAIR
affiliation: University of Geneva, Switzerland
name: Thomas Perneger, Statistician
role: STUDY_CHAIR
affiliation: St George's Hospital, London, UK
name: Andrew Rhodes, PhD
role: STUDY_CHAIR
affiliation: University of Vienna, Austria
name: Andreas Valentin, MD
role: STUDY_CHAIR
References:
citation: 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 admitted to Intensive Care Units in hospitals with and without Intermediate Care Units: a multicentre European cohort study. Crit Care. 2014 Oct 9;18(5):551. doi: 10.1186/s13054-014-0551-8.
citation: Poncet A, Perneger TV, Merlani P, Capuzzo M, Combescure C. Determinants of the calibration of SAPS II and SAPS 3 mortality scores in intensive care: a European multicenter study. Crit Care. 2017 Apr 4;21(1):85. doi: 10.1186/s13054-017-1673-6.