Trial Outcomes & Findings for European Mortality & Length Of Intensive Care Unit (ICU) Stay Evaluation (ELOISE) (NCT NCT01422070)

Results Overview

Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital

Recruitment status

COMPLETED

Target enrollment

6433 participants

Primary outcome timeframe

Max 90 days after admission to the Study Unit

Results posted on

2015-08-21

Participant Flow

All admissions of patients aged ≥ 16 years to a study during 28-day period (from 7 Nov to 4 Dec 2011, or from 16 Jan to 12 Feb 2012), excludind admissions only for organ donation, and with any limitation of care stated before unit admission. Maximum number of admissions per unit was 100.

Prospective observational study, without group assignment. Study units gave information about organization. 32 admissions to units with level of care lower than intensive care unit (ICU), 337 readmissions, 83 admissions out of the dates of enrollment slots, and 147 admissions with unknown vital status at hospital discharge were excluded.

Participant milestones

Participant milestones
Measure	Units in Hospitals With Intermediate Care Unit Adult patients consecutively admitted to Intensive Care Units in hospitals with intermediate care unit	Units in Hospitals Without Intermediate Care Unit Adult patients consecutively admitted to Intensive Care Units in hospitals without intermediate care unit
Overall Study STARTED	5031	803
Overall Study COMPLETED	5031	803
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Units With Intermediate Care Unit n=5031 Participants Patients admitted to intensive care unit with intermediate care unit in the hospital	Units Without Intermediate Care Unit n=803 Participants Patients admitted to intensive care unit without intermediate care unit in the hospital	Total n=5834 Participants Total of all reporting groups
Age, Continuous	65 years n=99 Participants	68 years n=107 Participants	65 years n=206 Participants
Sex: Female, Male Female	2002 Participants n=99 Participants	332 Participants n=107 Participants	2334 Participants n=206 Participants
Sex: Female, Male Male	3029 Participants n=99 Participants	471 Participants n=107 Participants	3500 Participants n=206 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Units in Hospitals With Intermediate Care Unit n=5031 Participants Patients admitted to intensive care unit with intermediate care unit in the hospital	Units in Hospitals Without Intermediate Care Unit n=803 Participants Patients admitted to intensive care unit without intermediate care unit in the hospital
Vital Status at Hospital Discharge	1232 participants	165 participants

SECONDARY outcome

Timeframe: Max 90 days after admission to intensive care unit

Number of days (calendar days -1) from admission to and discharge from the Study Unit

Outcome measures

Outcome measures
Measure	Units in Hospitals With Intermediate Care Unit n=5031 Participants Patients admitted to intensive care unit with intermediate care unit in the hospital	Units in Hospitals Without Intermediate Care Unit n=803 Participants Patients admitted to intensive care unit without intermediate care unit in the hospital
Length of ICU Stay	3.7 days Interval 1.9 to 7.7	2.8 days Interval 1.8 to 4.8

SECONDARY outcome

Timeframe: Max 90 days after admission to the Study Unit

Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital

Outcome measures

Outcome measures
Measure	Units in Hospitals With Intermediate Care Unit n=5031 Participants Patients admitted to intensive care unit with intermediate care unit in the hospital	Units in Hospitals Without Intermediate Care Unit n=803 Participants Patients admitted to intensive care unit without intermediate care unit in the hospital
Length of Hospital Stay	13.9 days Interval 7.6 to 25.0	11.0 days Interval 6.2 to 11.0

SECONDARY outcome

Timeframe: Max 90 days after admission to the Study Unit

Number of readmissions to intensive care unit during the same hospital course

Outcome measures

Outcome measures
Measure	Units in Hospitals With Intermediate Care Unit n=5031 Participants Patients admitted to intensive care unit with intermediate care unit in the hospital	Units in Hospitals Without Intermediate Care Unit n=803 Participants Patients admitted to intensive care unit without intermediate care unit in the hospital
Number of ICU Readmissions	292 readmissions	40 readmissions

Adverse Events

Adverse Events Not Collected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Maurizia Capuzzo

Università degli Studi di Ferrara

Phone: +393355932642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place