Hospital MortalityNCT02347150
International Multicenter Study of In-hospital Outcome of Patients After ICU Discharge
An observational study of Hospital Mortality, run by Hospital Vila Franca de Xira at 3 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Mortality
- How many people
- 3,000 participants
- Where
- 3 sitesPortugal
- Study dates
- Mar 2015to Jun 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients discharge from the ICU with a ICU LOS>24h
Who may be able to join
- Consecutive patients discharged from the ICU with LOS>24h
Who cannot join
- Presence of limitation of care decision
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites, 3 recruiting
- Recruiting
Hospital Fernando da Fonseca
Amadora
Michele Costa, MD, michelecosta21@gmail.com
Paulo Freitas, MD, ptf@netcabo.pt
- Recruiting
Hospital Nélio Mendonça
Funchal
Margarida Camara, MD, mcamara.pt@gmail.com
Julio Nobrega, MD, jjpnobrega@gmail.com
- Recruiting
Hospital Vila Franca de Xira
Vila Franca de Xira
João Gonçalves Pereira, joaogpster@gmail.com
David Nora, davidjgarcianora@gmail.com
About this study
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.
Read more
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.
Read the 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
- Conditions
- Hospital Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU LOS>24h | 30-110 patients discharged from the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
In hospital mortality after discharge from the ICU
Measured: 6 months
Secondary outcomes (1)
Hospital length of stay
Time between ICU admission and hospital discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital Vila Franca de Xira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Gonçalves-Pereira, Hospital Vila Franca de Xira
- Investigators
- João Goncalves-Pereira, MD, Principal investigator, Hospital Vila Franca de Xira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347150
- Sponsor's protocol ID
- HVFX01
- Status last verified
- Aug 2015
- First submitted
- 16 Jan 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Study of In-hospital Outcome of Patients After ICU Discharge
- ClinicalTrials.gov ID
- NCT02347150
- Acronym / sponsor ID
- HVFX01
- Conditions
- Hospital Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Hospital Vila Franca de XiraUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU LOS>24h | – | –30-110 patients discharged from the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients discharge from the ICU with a ICU LOS>24h
Key inclusion criteria (1 listed)
- Consecutive patients discharged from the ICU with LOS>24h
Key exclusion criteria (1 listed)
- Presence of limitation of care decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In hospital mortality
Time frame: 6 months
In hospital mortality after discharge from the ICU
1 secondary outcome
Hospital length of stay
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Goncalves-Pereira, MD principal investigator
Hospital Vila Franca de Xira
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Mortality, run by Hospital Vila Franca de Xira at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Goncalves-Pereira, MD (+351962441546, joaogpster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.