Semi-intensive Care UnitNCT04676347
Health-care Quality in Semi-intensive Care Units
An observational study of Semi-intensive Care Unit and Evaluation, run by Mario Negri Institute for Pharmacological Research at 18 sites in Italy.
Trial summary
The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Semi-intensive Care Unit, Evaluation, Quality
- How many people
- 39,000 participants
- Where
- 18 sitesItaly
- Study dates
- 1 Jul 2021to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- all patients hospitalised in a semi-intensive care unit
Who cannot join
- None
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Italy18 sites, 16 recruiting
- Recruiting
ASO SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Riccardo Boverio, rboverio@ospedale.al.it
- Recruiting
Ospedale San Bassiano
Bassano del Grappa
Niccolò Zanforlin, MD, francesca.salsa@aulss7.veneto.it
- Recruiting
Ospedale Maggiore
Bologna
Soccorsa Sofia, MD, soccorsa.sofia@ausl.bologna.it
- Recruiting
AOU Policlinico S. Marco
Catania
Paola Noto, MD, p.noto@hotmail.it
- Recruiting
Ospedale Bufalini
Cesena
Patrizia Cuppini, MD, patrizia.cuppini@auslromagna.it
- Not yet recruiting
Ospedali Riuniti
Livorno
Emanuela Chella, MD, chella.emanuela@gmail.com
- Not yet recruiting
ASST Lodi
Lodi
Giulia Acquistapace, MD, Giulia.Acquistapace@asst-lodi.it
- Active, not recruiting
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Milan, Milan, 20156
- Recruiting
Ospedale Santa Maria delle Grazie
Naples
Giovanni Porta, MD, dottorgiovanniporta@gmail.com
- Recruiting
AOU San Luigi Gonzaga
Orbassano, 10043
Valeria Caramello, v.caramello@sanluigi.piemonte.it
- Recruiting
AOU Padova
Padova
Agata Barchitta, +39 049 8211252, agathabarchitta@gmail.com
- Recruiting
Ospedale E.Agnelli
Pinerolo, 10064
Davide Lison, dlison@aslto3.piemonte.it
- Recruiting
Ospedale degli Infermi
Rivoli
Paola Molino, +39 011 9551040, paola.molino@aslto3.piemonte.it
- Recruiting
Ospedale Sant'Eugenio
Roma, 00144
Enrico Mirante, enrico.mirante@aslroma2.it
Ersilia Castaldo, ersilia.castaldo@gmail.com
- Recruiting
AOU di Sassari
Sassari
Paolo Pinna Parpaglia, MD, paolo.pinnaparpaglia@aousassari.it
- Recruiting
Ospedale Giovanni Bosco
Torino
Marcella Converso, MD, lellaconverso@tiscali.it
- Active, not recruiting
Ospedale Ca' Foncello
Treviso
- Recruiting
Ospedale Michele e Pietro Ferrero
Verduno
Antonio Scarfone, ascarfone@aslcn2.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Semi-intensive Care Unit, Evaluation, Quality
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Outcome for stationary patients with high risk of variability
hospitalization in semi-intensive care unit more than 2 days or transfer to intensive care unit
Measured: jan 2021 - dec 2025
Outcome for low gravity patients, with a low organ's damage
deterioration of the physiopathologic index
Measured: jan 2021 - dec 2025
Outcome for semi-intensive patients
transfer to intensive care unit or hospital mortality
Measured: jan 2021 - dec 2025
Outcome for high risk patients
transfer to intensive care unit or hospital mortality
Measured: jan 2021 - dec 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jul 2021
- Primary completion1 Dec 2022
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Semi-intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- 39,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676347
- Sponsor's protocol ID
- IRFMN_7998
- Status last verified
- May 2026
- First submitted
- 15 Dec 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Improvement of the Health-care Quality in Semi-intensive Care Units
- ClinicalTrials.gov ID
- NCT04676347
- Acronym / sponsor ID
- IRFMN_7998
- Conditions
- Semi-intensive Care Unit, Evaluation, Quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39,000 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Dec 2020 (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.
The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- all patients hospitalised in a semi-intensive care unit
Key exclusion criteria (1 listed)
- None
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
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
Outcome for low gravity patients, with a low organ's damage
Time frame: jan 2021 - dec 2025
deterioration of the physiopathologic index
Outcome for semi-intensive patients
Time frame: jan 2021 - dec 2025
transfer to intensive care unit or hospital mortality
Outcome for high risk patients
Time frame: jan 2021 - dec 2025
transfer to intensive care unit or hospital mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided. 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
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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Semi-intensive Care Unit and Evaluation, run by Mario Negri Institute for Pharmacological Research at 18 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 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: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guido Bertolini (035 4535389, guido.bertolini@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome for stationary patients with high risk of variability (time frame: jan 2021 - dec 2025). The study lists 4 primary outcomes in all. 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 20 May 2026.