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Clinical Trials/NCT02347150
NCT02347150UnknownNot Applicable

International Multicenter Study of In-hospital Outcome of Patients After ICU Discharge

Hospital Vila Franca de Xira3 sites in 1 country3,000 target enrollmentStarted: March 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
3,000
Locations
3
Primary Endpoint
In hospital mortality

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Consecutive patients discharged from the ICU with LOS>24h

Exclusion Criteria

  • Presence of limitation of care decision

Outcomes

Primary Outcomes

In hospital mortality

Time Frame: 6 months

In hospital mortality after discharge from the ICU

Secondary Outcomes

  • Hospital length of stay(6 months)

Investigators

Sponsor
Hospital Vila Franca de Xira
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

João Gonçalves-Pereira

MD

Hospital Vila Franca de Xira

Study Sites (3)

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