Critical IllnessELOISENCT01422070
European Mortality & Length Of Intensive Care Unit (ICU) Stay Evaluation (ELOISE)
An observational study of Critical Illness, run by Università degli Studi di Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 6,433 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Jun 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult patients consecutively admitted to the Study Units during one month (from 7th November to 4th December 2010)
Who may be able to join
- admission to one of the Study Unit
- any organ support allowed
- age of at least 16 years
Who cannot join
- age lower than 16 years
- patients admitted as donor for transplant
- patients admitted with limitation of care stated before admission
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients admitted to ICUs with or without availability of IMCU.
- To assess the influence of IMCU on the rate of ICU readmissions.
- 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.
Read the 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.
- Conditions
- Critical Illness
- Keywords
- mortality, intensive care, critical care, intermediate care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Status at Hospital Discharge
Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital
Measured: Max 90 days after admission to the Study Unit
Secondary outcomes (3)
Length of ICU Stay
Number of days (calendar days -1) from admission to and discharge from the Study Unit
Measured: Max 90 days after admission to intensive care unit
Length of Hospital Stay
Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital
Measured: Max 90 days after admission to the Study Unit
Number of ICU Readmissions
Number of readmissions to intensive care unit during the same hospital course
Measured: Max 90 days after admission to the Study Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Ferrara, European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Maurizia Capuzzo, Università degli Studi di Ferrara
- Investigators
- Maurizia Capuzzo, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Ferrara, ItalyChristophe Combescure, Statistician, Study chair, University of Geneva, SwitzerlandBertrand Guidet, PhD, Study chair, Hôpital Saint-Antoine, Paris, FranceGaetano Iapichino, MD, Study chair, Hospital San Paolo, University of Milan, ItalyPaolo Merlani, MD, Study chair, University of Geneva, SwitzerlandRui P Moreno, PhD, Study chair, Hospital de Santo Antonio dos Capuchos, Lisbon, PortugalThomas Perneger, Statistician, Study chair, University of Geneva, SwitzerlandAndrew Rhodes, PhD, Study chair, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422070
- Sponsor's protocol ID
- 80-2011
- Acronym
- ELOISE
- Status last verified
- Jul 2015
- First submitted
- 19 Aug 2011
- Last updated
- 21 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25664865Poncet 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.
PubMed 28376908
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01422070
- Acronym / sponsor ID
- ELOISE / 80-2011
- Conditions
- Critical Illness
- Keywords
- mortality, intensive care, critical care, intermediate care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,433 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- University Hospital of Ferrara, European Society of Intensive Care Medicine
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients admitted to ICUs with or without availability of IMCU.
- To assess the influence of IMCU on the rate of ICU readmissions.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult patients consecutively admitted to the Study Units during one month (from 7th November to 4th December 2010)
Key inclusion criteria (3 listed)
- admission to one of the Study Unit
- any organ support allowed
- age of at least 16 years
Key exclusion criteria (3 listed)
- age lower than 16 years
- patients admitted as donor for transplant
- patients admitted with limitation of care stated before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vital Status at Hospital Discharge
Time frame: Max 90 days after admission to the Study Unit
Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital
3 secondary outcomes
Length of ICU Stay
Time frame: Max 90 days after admission to intensive care unit
Length of Hospital Stay
Time frame: Max 90 days after admission to the Study Unit
Number of ICU Readmissions
Time frame: Max 90 days after admission to the Study Unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25664865Capuzzo 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.
- Derived from this study: PubMed 28376908Poncet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizia Capuzzo, MD principal investigator
Azienda Ospedaliero-Universitaria di Ferrara, Italy
Christophe Combescure, Statistician study chair
University of Geneva, Switzerland
Bertrand Guidet, PhD study chair
Hôpital Saint-Antoine, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Status at Hospital Discharge (time frame: Max 90 days after admission to the Study Unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422070, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.