In-Hospital MortalityNCT02599636
To Survive After ICU Discharge
An observational study of In-Hospital Mortality and Number of ICU Readmission, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial summary
Many factors before and after ICU stay determine the outcome of patients at ICU discharge, the type of illness, physical dependence and other sequelae can be a trigger for complications in hospital ward which can induce ICU readmission and worse outcome. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- In-Hospital Mortality, Number of ICU Readmission, Number of Warnings On-duty
- What is being tested?
- None intervention
- How many people
- 1,200 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Sep 2016
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients at ICU discharge
Who may be able to join
- All patients with Sabadell Score 1 (poor prognosis in long term) and 2 (poor prognosis in short term) at ICU discharge
Who cannot join
- patients younger than 18 years old
- patients with Sabadell Score 0 (good prognosis)
- patients with Sabadell Score 3 (null expected survival)
- patients transferred to other hospitals
Trial locations and contacts
1 site in 1 country.
Spain1 site
Althaia Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, 08243
About this study
Official title: Multicenter Prospective Study: To Survive After ICU Discharge
Many factors before and after ICU stay determine the outcome of patients at ICU discharge, the type of illness, physical dependence and other sequelae can be a trigger for complications in hospital ward which can induce ICU readmission and worse outcome. The quality of medical assistance during all the hospitalisation should be guaranteed and many complications or fatal events could be avoidable.
The objective of the present study is to demonstrate that collaboration between the intensivist and other medical teams in ward can reduce ICU readmission and hospital mortality after ICU discharge.
Read the detailed description
Material and Methods This observational multicenter study will be done in 21 medical-surgical ICUs. We will use Sabadell Score like prognostic scale at ICU discharge and the intensivist will collaborate with the medical team in medical assistance of patients at risk (Sabadell Score 1 and 2). Investigators will compare the hospital mortality and the readmission rate with a previous period when this collaboration didn't exist.
Anticipate results The collaboration of attending intensivist might reduce ward mortality after ICU discharge by 3%.
- Being tested
- None intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None interventionOther
Investigators will study the usual medical assistance
What is being measured
The primary outcome is the main question the study is designed to answer.
The decline in hospital mortality
Measured: 3 months
Secondary outcomes (1)
The decline in number of warnings on-duty
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Cano Hernández, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Silvia Cano Hernández, Physician, Principal investigator, Althaia Xarxa Assistencial Universitaria de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599636
- Sponsor's protocol ID
- Althaia
- Status last verified
- Jul 2016
- First submitted
- 30 Oct 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study: To Survive After ICU Discharge
- ClinicalTrials.gov ID
- NCT02599636
- Acronym / sponsor ID
- Althaia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 6 Nov 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.
Many factors before and after ICU stay determine the outcome of patients at ICU discharge, the type of illness, physical dependence and other sequelae can be a trigger for complications in hospital ward which can induce ICU readmission and worse outcome. The quality of medical assistance during all the hospitalisation should be guaranteed and many complications or fatal events could be avoidable.
The objective of the present study is to demonstrate that collaboration between the intensivist and other medical teams in ward can reduce ICU readmission and hospital mortality after ICU discharge.
Detailed description
Material and Methods This observational multicenter study will be done in 21 medical-surgical ICUs. We will use Sabadell Score like prognostic scale at ICU discharge and the intensivist will collaborate with the medical team in medical assistance of patients at risk (Sabadell Score 1 and 2). Investigators will compare the hospital mortality and the readmission rate with a previous period when this collaboration didn't exist.
Anticipate results The collaboration of attending intensivist might reduce ward mortality after ICU discharge by 3%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients at ICU discharge
Key inclusion criteria (1 listed)
- All patients with Sabadell Score 1 (poor prognosis in long term) and 2 (poor prognosis in short term) at ICU discharge
Key exclusion criteria (4 listed)
- patients younger than 18 years old
- patients with Sabadell Score 0 (good prognosis)
- patients with Sabadell Score 3 (null expected survival)
- patients transferred to other hospitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None interventionInvestigators will study the usual medical assistance | Other | – |
Primary outcome
The decline in hospital mortality
Time frame: 3 months
1 secondary outcome
The decline in number of warnings on-duty
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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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.
Silvia Cano Hernández, Physician principal investigator
Althaia Xarxa Assistencial Universitaria de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-Hospital Mortality and Number of ICU Readmission, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
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 4 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decline in hospital mortality (time frame: 3 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 14 Jul 2016.