HospitalizationSISIFONCT03651414
Safety Issues and SurvIval For Medical Outliers
An observational study of Hospitalization, run by Fadoi Foundation, Italy at 32 sites in Italy.
Trial summary
Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" and 30 patients "control". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- Clinical data collection
- How many people
- 2,056 participants
- Where
- 32 sitesItaly
- Study dates
- 19 Oct 2018to 7 Jul 2020
- 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 hospitalized for any cause.
Who may be able to join
- Outlier:
- Age ≥ 18 years
- Signature of informed consent
- Patients coming from Emergency Room
- Patients to be hospitalized in Internal Medicine or similar (not day-hospital)
- Patients spending at least one night in another ward for lack of available beds
Show all 14Show fewer
- Consecutive cases
- Control:
- Age ≥ 18 years
- Signature of informed consent
- Patients coming from Emergency Room
- Patients to be hospitalized in Internal Medicine or similar (not day-hospital)
- Patients hospitalized ab initio in Internal Medicine or similar for at least one night
- Consecutive cases
Who cannot join
- Age < 18 years
- Patients hospitalized in Internal Medicine or similar coming from other wards or directly from home
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Italy32 sites
Ospedale di Bisceglie - Trani
Bisceglie
Azienda Ospedaliera Brotzu
Cagliari
Ospedale Santissima Trinità
Cagliari
Ospedale Cervesi
Cattolica
Ospedale di Conegliano
Conegliano
Istituti Ospitalieri di Cremona
Cremona
Ospedale Morgagni Pierantoni
Forlì
Ospedale Evangelico
Genova
Ospedale Policlinico S. Martino
Genova
Ospedale Villa Scassi
Genova
Ospedale Sant'Andrea
La Spezia
Ospedale S. Maria Goretti
Latina
Ospedale di Lavagna
Lavagna
Ospedale di Legnano
Legnano
Ospedale di Magenta
Magenta
Ospedale San Carlo Borromeo
Milan
Ospedale Buon Consiglio Fatebenefratelli
Naples
Ospedale Felice Lotti
Pontedera
Nuovo Ospedale S. Stefano
Prato
Ospedale Infermi
Rimini
Ospedale San Giovanni Calibita Fatebenefratelli
Roma
Ospedale San'Antonio
San Daniele del Friuli
Ospedale Nostra Signora di Bonaria
San Gavino Monreale
Ospedale G. Borea
Sanremo
Ospedale San Bartolomeo
Sarzana
Ospedale Civile SS Annunziata
Sassari
Ospedale di Sestri Levante
Sestri Levante
Azienda Ospedaliera S. Maria
Terni
Ospedale Cottolengo
Torino
Ospedale di Treviglio
Treviglio
Ospedale Sant'Andrea
Vercelli
Ospedale Civile di Voghera
Voghera
About this study
Official title: Safety Issues and SurvIval For Medical Outliers (SISIFO) - Not-for-profit Observational Study to Evaluate the Quality and Safety of Care in Patients "Outliers" Hospitalized With Medical Diseases
Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" and 30 patients "control".
Read the detailed description
Phase 1 - Patients enrollment (October 2018 - May 2019) Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" (max 10 per month) and 30 patients "control" (max 6 per month). It will be collected clinical and organisational information. The Investigators of the wards that will not have patients "outliers" will have to enroll 70 patients "control" (max 15 per month).
Phase 2 - Database review and validation (June 2019 - October 2019) The data collected will be analysed to process the endpoints.
- Conditions
- Hospitalization
- Being tested
- Clinical data collection
- Keywords
- Outliers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
There will not be any experimental intervention. The study will be conducted according with normal clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients hospitalized ab initio in Internal Medicine or similar for at least one night Receives: Other: Clinical data collection | |
| Outlier | Patients spending at least one night in a ward different from Internal Medicine despite the presence of medical diseases, due to lack of available beds Receives: Other: Clinical data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhospital mortality
Evaluation of the inhospital mortality in patients "outliers" compared to patients that are hospitalized ab initio in the relevant ward (Internal Medicine - patients "control")
Measured: 8 months
Secondary outcomes (2)
Adverse Events
Evaluation of the adverse events in patients "outliers" compared to patients that are hospitalized ab initio in the relevant ward (Internal Medicine - patients "control")
Measured: 8 months
Mortality rate
Mortality rate after 30 days and after 3 months from the hospitalization
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 posted29 Aug 2018
- Study start19 Oct 2018
- Primary completion7 Apr 2020
- Study completion7 Jul 2020
Why it stopped: Due to health emergency Covid-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova
- Responsible party
- Sponsor
- Investigators
- Mauro Campanini, Study director, FADOI Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651414
- Sponsor's protocol ID
- FADOI.08.2018
- Acronym
- SISIFO
- Status last verified
- Feb 2025
- First submitted
- 24 Aug 2018
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Issues and SurvIval For Medical Outliers (SISIFO) - Not-for-profit Observational Study to Evaluate the Quality and Safety of Care in Patients "Outliers" Hospitalized With Medical Diseases
- ClinicalTrials.gov ID
- NCT03651414
- Acronym / sponsor ID
- SISIFO / FADOI.08.2018
- Conditions
- Hospitalization
- Keywords
- Outliers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to health emergency Covid-19.
- Enrolment
- 2,056 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Collaborators
- University of Genova
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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.
Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" and 30 patients "control".
Detailed description
Phase 1 - Patients enrollment (October 2018 - May 2019) Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" (max 10 per month) and 30 patients "control" (max 6 per month). It will be collected clinical and organisational information. The Investigators of the wards that will not have patients "outliers" will have to enroll 70 patients "control" (max 15 per month).
Phase 2 - Database review and validation (June 2019 - October 2019) The data collected will be analysed to process the endpoints.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Clinical data collectionPatients hospitalized ab initio in Internal Medicine or similar for at least one night |
| Outlier | – | Other: Clinical data collectionPatients spending at least one night in a ward different from Internal Medicine despite the presence of medical diseases, due to lack of available beds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for any cause.
Key inclusion criteria (14 listed)
- Age ≥ 18 years
- Signature of informed consent
- Patients coming from Emergency Room
- Patients to be hospitalized in Internal Medicine or similar (not day-hospital)
- Patients spending at least one night in another ward for lack of available beds
Key exclusion criteria (2 listed)
- Age < 18 years
- Patients hospitalized in Internal Medicine or similar coming from other wards or directly from home
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 |
|---|---|---|
| Clinical data collectionThere will not be any experimental intervention. The study will be conducted according with normal clinical practice. | Other | Control, Outlier |
Primary outcome
Inhospital mortality
Time frame: 8 months
Evaluation of the inhospital mortality in patients "outliers" compared to patients that are hospitalized ab initio in the relevant ward (Internal Medicine - patients "control")
2 secondary outcomes
Adverse Events
Time frame: 8 months
Mortality rate
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Due to health emergency Covid-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
Mauro Campanini study director
FADOI Foundation
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization, run by Fadoi Foundation, Italy at 32 sites in Italy.
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 14 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Italy. 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?
The study was stopped early (reason given: Due to health emergency Covid-19.). 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?
Inhospital mortality (time frame: 8 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 10 Feb 2025.