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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04676347
Other study ID # IRFMN_7998
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date December 2025

Study information

Verified date December 2023
Source Mario Negri Institute for Pharmacological Research
Contact Guido Bertolini
Phone 035 4535389
Email guido.bertolini@marionegri.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 39000
Est. completion date December 2025
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all patients hospitalised in a semi-intensive care unit Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy ASO SS Antonio e Biagio e Cesare Arrigo Alessandria
Italy Ospedale Umberto Parini Aosta
Italy AOU Policlinico S. Marco Catania
Italy AOU Policlinico San Marco Catania
Italy Ospedale Bufalini Cesena
Italy Ospedale Santa Maria Annunziata Firenze
Italy Ospedale Morgagni-Pierantoni Forlì
Italy Ospedale Palmanova-Latisana Latisana
Italy Ospedali Riuniti Livorno
Italy ASST Lodi Lodi
Italy Istituto di Ricerche Farmacologiche Mario Negri IRCCS Milan
Italy Ospedale Santa Maria delle Grazie Napoli
Italy AOU San Luigi Gonzaga Orbassano
Italy Ospedale Guglielmo da Saliceto Piacenza
Italy Ospedale E.Agnelli Pinerolo
Italy AOU Pisana Pisa
Italy Ospedale Santa Maria delle Croci Ravenna
Italy Ospedale Sant'Eugenio Roma
Italy AOU di Sassari Sassari
Italy Ospedale Giovanni Bosco Torino
Italy Ospedale Ca' Foncello Treviso
Italy Santa Maria della Misericordia Udine

Sponsors (1)

Lead Sponsor Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 jan 2021 - dec 2025
Primary Outcome for low gravity patients, with a low organ's damage deterioration of the physiopathologic index jan 2021 - dec 2025
Primary Outcome for semi-intensive patients transfer to intensive care unit or hospital mortality jan 2021 - dec 2025
Primary Outcome for high risk patients transfer to intensive care unit or hospital mortality jan 2021 - dec 2025
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