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

NCT01422070 | Completed Results

• 1 other identifier: 80-2011
• Study Type: observational
• Target: 6,433
• Locations: 1 country
• Sites: 1

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. 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. 2.To assess the influence of IMCU on the rate of ICU readmissions.
3. 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

Keywords

mortality; intensive care; critical care; intermediate care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Length of ICU Stay

  Max 90 days after admission to intensive care unit

• Length of Hospital Stay

  Max 90 days after admission to the Study Unit

• Number of ICU Readmissions

  Max 90 days after admission to the Study Unit

Study Arms (1)

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)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• admission to one of the Study Unit
• any organ support allowed
• age of at least 16 years

You may not qualify if:

• age lower than 16 years
• patients admitted as donor for transplant
• patients admitted with limitation of care stated before admission

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• University Hospital of Ferrara: collaborator
• European Society of Intensive Care Medicine: collaborator

Study Sites (1)

Maurizia Capuzzo

Ferrara, 44121, Italy

Location

Related Publications (2)

• 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.

  PMID: 25664865 RESULT

• 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.

  PMID: 28376908 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Maurizia Capuzzo
• Organization: Università degli Studi di Ferrara

cpm@unife.it

+393355932642

Study Officials

• Maurizia Capuzzo, MD

  Azienda Ospedaliero-Universitaria di Ferrara, Italy

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 21, 2015
• Results First Posted: March 2, 2015

Record last verified: 2015-07

Locations

IT (1)