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

NCT ID: NCT02347150

Last Updated: 2015-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hospital Mortality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICU LOS>24h

30-110 patients discharged from the ICU

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Presence of limitation of care decision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Vila Franca de Xira

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

João Gonçalves-Pereira

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

João Goncalves-Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vila Franca de Xira

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Fernando da Fonseca

Amadora, , Portugal

Site Status RECRUITING

Hospital Nélio Mendonça

Funchal, , Portugal

Site Status RECRUITING

Hospital Vila Franca de Xira

Vila Franca de Xira, , Portugal

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

João Goncalves-Pereira, MD

Role: CONTACT

+351962441546

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michele Costa, MD

Role: primary

Paulo Freitas, MD

Role: backup

Margarida Camara, MD

Role: primary

Julio Nobrega, MD

Role: backup

João Gonçalves Pereira

Role: primary

David Nora

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HVFX01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The ICU LIBERATION Study
NCT05844579 RECRUITING