- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04676347
Health-care Quality in Semi-intensive Care Units
May 18, 2026 updated by: Mario Negri Institute for Pharmacological Research
Evaluation and Improvement of the Health-care Quality in Semi-intensive Care Units
The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Collecting data of semi-intensive care units' patients and structural data of hospitals, healthcare quality's indicators will be realized.
Starting from those indicators of insuccess, specific for different kinds of patients, it will be possibile to evaluate the general level of care in each singular semi-intensive care unit.
The study will least for 5 years, but at the end of every year it will be realized a report of analysis to see the results of each unit.
Study Type
Observational
Enrollment (Estimated)
39000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guido Bertolini
- Phone Number: 035 4535389
- Email: guido.bertolini@marionegri.it
Study Contact Backup
- Name: Giulia Irene Ghilardi
- Phone Number: 035 4535389
- Email: giulia_irene.ghilardi@marionegri.it
Study Locations
-
-
-
Alessandria, Italy, 15121
- Recruiting
- ASO SS Antonio e Biagio e Cesare Arrigo
-
Contact:
- Riccardo Boverio
- Email: rboverio@ospedale.al.it
-
Bassano del Grappa, Italy
- Recruiting
- Ospedale San Bassiano
-
Contact:
- Niccolò Zanforlin, MD
- Email: francesca.salsa@aulss7.veneto.it
-
Bologna, Italy
- Recruiting
- Ospedale Maggiore
-
Contact:
- Soccorsa Sofia, MD
- Email: soccorsa.sofia@ausl.bologna.it
-
Catania, Italy
- Recruiting
- AOU Policlinico S. Marco
-
Contact:
- Paola Noto, MD
- Email: p.noto@hotmail.it
-
Cesena, Italy
- Recruiting
- Ospedale Bufalini
-
Contact:
- Patrizia Cuppini, MD
- Email: patrizia.cuppini@auslromagna.it
-
Livorno, Italy
- Not yet recruiting
- Ospedali Riuniti
-
Contact:
- Emanuela Chella, MD
- Email: chella.emanuela@gmail.com
-
Lodi, Italy
- Not yet recruiting
- ASST Lodi
-
Contact:
- Giulia Acquistapace, MD
- Email: Giulia.Acquistapace@asst-lodi.it
-
Naples, Italy
- Recruiting
- Ospedale Santa Maria delle Grazie
-
Contact:
- Giovanni Porta, MD
- Email: dottorgiovanniporta@gmail.com
-
Orbassano, Italy, 10043
- Recruiting
- AOU San Luigi Gonzaga
-
Contact:
- Valeria Caramello
- Email: v.caramello@sanluigi.piemonte.it
-
Padova, Italy
- Recruiting
- AOU Padova
-
Contact:
- Agata Barchitta
- Phone Number: +39 049 8211252
- Email: agathabarchitta@gmail.com
-
Pinerolo, Italy, 10064
- Recruiting
- Ospedale E.Agnelli
-
Contact:
- Davide Lison
- Email: dlison@aslto3.piemonte.it
-
Rivoli, Italy
- Recruiting
- Ospedale degli Infermi
-
Contact:
- Paola Molino
- Phone Number: +39 011 9551040
- Email: paola.molino@aslto3.piemonte.it
-
Roma, Italy, 00144
- Recruiting
- Ospedale Sant'Eugenio
-
Contact:
- Enrico Mirante
- Email: enrico.mirante@aslroma2.it
-
Contact:
- Ersilia Castaldo
- Email: ersilia.castaldo@gmail.com
-
Sassari, Italy
- Recruiting
- AOU di Sassari
-
Contact:
- Paolo Pinna Parpaglia, MD
- Email: paolo.pinnaparpaglia@aousassari.it
-
Torino, Italy
- Recruiting
- Ospedale Giovanni Bosco
-
Contact:
- Marcella Converso, MD
- Email: lellaconverso@tiscali.it
-
Treviso, Italy
- Active, not recruiting
- Ospedale Ca' Foncello
-
Verduno, Italy
- Recruiting
- Ospedale Michele e Pietro Ferrero
-
Contact:
- Antonio Scarfone
- Email: ascarfone@aslcn2.it
-
-
Milan
-
Milan, Milan, Italy, 20156
- Active, not recruiting
- Istituto di Ricerche Farmacologiche Mario Negri IRCCS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
all patients hospitalised in a semi-intensive care unit attending the study, during a 5 years period of time (from 1st january 2021, to 31st december 2025)
Description
Inclusion Criteria:
- all patients hospitalised in a semi-intensive care unit
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Eligible population
All patients admitted in the semi-intensive care units attending the study.
Be basing on the average number of patients yearly treated in those units, we expect to have at least 39000 patients during the 5 years of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome for stationary patients with high risk of variability
Time Frame: jan 2021 - dec 2025
|
hospitalization in semi-intensive care unit more than 2 days or transfer to intensive care unit
|
jan 2021 - dec 2025
|
|
Outcome for low gravity patients, with a low organ's damage
Time Frame: jan 2021 - dec 2025
|
deterioration of the physiopathologic index
|
jan 2021 - dec 2025
|
|
Outcome for semi-intensive patients
Time Frame: jan 2021 - dec 2025
|
transfer to intensive care unit or hospital mortality
|
jan 2021 - dec 2025
|
|
Outcome for high risk patients
Time Frame: jan 2021 - dec 2025
|
transfer to intensive care unit or hospital mortality
|
jan 2021 - dec 2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
December 1, 2022
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
December 15, 2020
First Submitted That Met QC Criteria
December 15, 2020
First Posted (Actual)
December 21, 2020
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- IRFMN_7998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Protecting the privacy policy, all the data that underlie results in a publication will be shared.
The scientific commettee of the study has to decide the criteria and the best way to share them
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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