Clinical trial NCT02347150: International Multicenter Study of In-hospital Outcome of Patients After ICU Discharge
Official title: International Multicenter Study of In-hospital Outcome of Patients After ICU Discharge
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospital Mortality
Lead sponsor: Hospital Vila Franca de Xira
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients discharge from the ICU with a ICU LOS\>24h

Brief summary: Several patients die in the intensive care unit (ICU) due to their acute disease and comorbid conditions. Moreover, after ICU discharge, some ICU survivors still die in the wards.

Previous studies have shown that the clinical condition of the patient at the time of ICU discharge may influence in-hospital prognosis. Non-modifiable factors, such as age and comorbid conditions certainly play a role. But inflammatory status (especially C-reactive protein - CRP), Sequential organ failure score (SOFA) score and Therapeutic intervention scoring system (TISS) 28 score have also been related with the risk of hospital death.

Admission to a high dependency unit may reduce the ICU length of stay (LOS). This strategy may also help to improve prognosis contributing to further stabilize the patient, facilitate his autonomy and the removal of invasive devices. However the benefit of a step-down strategy (from ICU to a high dependency unit) has never been evaluated.

The development of a score to evaluate the risk of patients discharged from the ICU may help to improve the allocation of resources, either to prolong the ICU stay, or admission to a high dependency units or the ward.

Detailed description: Methods Prospective, observational, international, multicentre study to be conducted in 2 countries (Portugal, Brazil). Inclusion criteria: Each centre may include a maximum of 110 consecutive patients discharged from the ICU with length of stay (LOS)\>24h during a 6 month period.

Exclusion criteria: Limitation of care decision Primary objective: To determine the impact in hospital mortality and LOS (ICU and hospital) of a step-down strategy, from the ICU to a high dependency unit, before admission to the ward.

Secondary objectives: To develop and validate a score of the risk of death in the hospital after discharge from the ICU

Eligibility criteria: Inclusion Criteria:

* Consecutive patients discharged from the ICU with LOS\>24h

Exclusion Criteria:

* Presence of limitation of care decision

Primary outcomes:
measure: In hospital mortality
timeFrame: 6 months
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Amadora
country: Portugal
facility: Hospital Fernando da Fonseca
city: Funchal
country: Portugal
facility: Hospital Nélio Mendonça
city: Vila Franca de Xira
country: Portugal
facility: Hospital Vila Franca de Xira
Study officials:
affiliation: Hospital Vila Franca de Xira
name: João Goncalves-Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: