NCT02347150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

January 16, 2015

Last Update Submit

August 17, 2015

Conditions

Hospital Mortality

Outcome Measures

Primary Outcomes (1)

  • In hospital mortality

    In hospital mortality after discharge from the ICU

    6 months

Secondary Outcomes (1)

  • Hospital length of stay

    6 months

Study Arms (1)

ICU LOS>24h

30-110 patients discharged from the ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Presence of limitation of care decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Fernando da Fonseca

Amadora, Portugal

RECRUITING

Hospital Nélio Mendonça

Funchal, Portugal

RECRUITING

Hospital Vila Franca de Xira

Vila Franca de Xira, Portugal

RECRUITING

Study Officials

  • João Goncalves-Pereira, MD

    Hospital Vila Franca de Xira

    PRINCIPAL INVESTIGATOR

Central Study Contacts

João Goncalves-Pereira, MD

CONTACT

+351962441546joaogpster@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 27, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

PT(3)