Study Stopped
Due to health emergency Covid-19.
Safety Issues and SurvIval For Medical Outliers
SISIFO
1 other identifier
observational
2,056
1 country
32
Brief Summary
Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" and 30 patients "control".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
32 active sites
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
August 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2020
CompletedFebruary 10, 2025
February 1, 2025
1.5 years
August 24, 2018
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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")
8 months
Secondary Outcomes (2)
Adverse Events
8 months
Mortality rate
3 months
Study Arms (2)
Control
Patients hospitalized ab initio in Internal Medicine or similar for at least one night
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
Interventions
There will not be any experimental intervention. The study will be conducted according with normal clinical practice.
Eligibility Criteria
Patients hospitalized for any cause.
You may qualify if:
- 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
- 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
You may not qualify if:
- Age \< 18 years
- Patients hospitalized in Internal Medicine or similar coming from other wards or directly from home
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fadoi Foundation, Italylead
- University of Genovacollaborator
Study Sites (32)
Ospedale di Bisceglie - Trani
Bisceglie, Italy
Azienda Ospedaliera Brotzu
Cagliari, Italy
Ospedale Santissima Trinità
Cagliari, Italy
Ospedale Cervesi
Cattolica, Italy
Ospedale di Conegliano
Conegliano, Italy
Istituti Ospitalieri di Cremona
Cremona, Italy
Ospedale Morgagni Pierantoni
Forlì, Italy
Ospedale Evangelico
Genova, Italy
Ospedale Policlinico S. Martino
Genova, Italy
Ospedale Villa Scassi
Genova, Italy
Ospedale Sant'Andrea
La Spezia, Italy
Ospedale S. Maria Goretti
Latina, Italy
Ospedale di Lavagna
Lavagna, Italy
Ospedale di Legnano
Legnano, Italy
Ospedale di Magenta
Magenta, Italy
Ospedale San Carlo Borromeo
Milan, Italy
Ospedale Buon Consiglio Fatebenefratelli
Napoli, Italy
Ospedale Felice Lotti
Pontedera, Italy
Nuovo Ospedale S. Stefano
Prato, Italy
Ospedale Infermi
Rimini, Italy
Ospedale San Giovanni Calibita Fatebenefratelli
Roma, Italy
Ospedale San'Antonio
San Daniele del Friuli, Italy
Ospedale Nostra Signora di Bonaria
San Gavino Monreale, Italy
Ospedale G. Borea
Sanremo, Italy
Ospedale San Bartolomeo
Sarzana, Italy
Ospedale Civile SS Annunziata
Sassari, Italy
Ospedale di Sestri Levante
Sestri Levante, Italy
Azienda Ospedaliera S. Maria
Terni, Italy
Ospedale Cottolengo
Torino, Italy
Ospedale di Treviglio
Treviglio, Italy
Ospedale Sant'Andrea
Vercelli, Italy
Ospedale Civile di Voghera
Voghera, Italy
Study Officials
- STUDY DIRECTOR
Mauro Campanini
FADOI Foundation
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2018
First Posted
August 29, 2018
Study Start
October 19, 2018
Primary Completion
April 7, 2020
Study Completion
July 7, 2020
Last Updated
February 10, 2025
Record last verified: 2025-02