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

August 17, 2015 updated by: João Gonçalves-Pereira, Hospital Vila Franca de Xira

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients discharge from the ICU with a ICU LOS>24h

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of limitation of care decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ICU LOS>24h
30-110 patients discharged from the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In hospital mortality
Time Frame: 6 months
In hospital mortality after discharge from the ICU
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: 6 months
Time between ICU admission and hospital discharge
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Vila Franca de Xira

Investigators

  • Principal Investigator: João Goncalves-Pereira, MD, Hospital Vila Franca de Xira

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • HVFX01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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