Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

NCT ID: NCT05780099

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-24
• Study Completion Date: 2032-09-10

Brief Summary

Patients referred to internal medicine wards are becoming increasingly complex and fragile. Despite deep knowledge of their specific disorders, steps are required to improve overall management of their acute and chronic conditions. The main objective of the study is to identify demographic, clinical, laboratory and radiological markers of disease severity and activity in patients with diseases treated at general medicine wards (respiratory disease, immune-mediated disease, sepsis, metabolic disease, rare disease, frailty, pregnancy pathology) in order to improve their diagnosis, monitoring and treatment processes.

Detailed Description

Among the most prevalent internal diseases worldwide are metabolic, respiratory and infectious diseases. Despite important progress in the field of these diseases, their frequent coexistence leads to a state of so-called fragility, now recognised as a genuine pathological condition, and entails the need to optimise their management in order to ensure faster and more effective diagnostic processes and targeted treatment procedures. On the other hand, those less frequent and less defined from both a pathogenetic and a management point of view include immune-mediated diseases, rare diseases, and internist disorders of pregnancy. Many times, diagnostic and therapeutic algorithms validated for specific diseases are arbitrarily applied to less common diseases based on the similarity of the clinical picture. For example, indices of inflammation such as C-reactive protein and erythrocyte sedimentation rate, traditionally used as markers of inflammatory response to infection, are commonly used as surrogate markers of disease activity in non-infectious immune-mediated diseases, despite the fact that there are no studies demonstrating their specific usefulness in patients suffering from them. This often leads to inappropriate care choices, as they are not based on sufficient degrees of evidence for those specific diseases. Studies focusing on specific disease categories are necessary to identify disease-specific markers and thus target therapy in an informed manner. Both the most prevalent and the least characterised pathologies require the integrated work of third-level centres, such as the San Raffaele Hospital, which have a large number of patient referrals and can therefore make a concrete contribution to the advancement of knowledge of these pathologies and their management and make their mark in the international scientific community. To this end, a prospective observational study is being conducted aimed at the detailed characterisation of patients suffering from these pathologies, in order to identify possible risk factors and markers of severity that can guide the development of new diagnostic and therapeutic strategies.

Conditions

Respiratory Disease; Cardiovascular Diseases; Infectious Disease; Critical Illness; Immunological Disease; Pregnancy Disease; Metabolic Syndrome; Chronic Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

patients treated at internal medicine wards

Inpatient or Outpatient visit

Intervention Type: OTHER

Patients will be seen and treated at the clinics like in the usual care

Interventions

Inpatient or Outpatient visit

Patients will be seen and treated at the clinics like in the usual care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Receving treatment at internal medicine departments (inpatient, outopatient, day hospital) of San Raffaele Hospital
• at least one suspected or confirmed diagnosis among:

1. immune mediated disorder

2. respiratory disorder

3. metabolic disorder

4. sepsis

5. rare disorder (according to Italian Ministry of Health list)

6. pregnancy-related disorder

7. frailty defined as: either ≥2 CIRS (Cumulative Illness Rating Scale) Severity Index 10 or ≤70% Karnofsky scale

Exclusion Criteria

• refusal to participate
• enrolment in other intervantional study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Rovere Querini Patrizia

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

San Raffaele Hospital

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Patrizia Rovere Querini, PhD, MD

Role: CONTACT

rovere.patrizia@hsr.it

+390226436095

Rebecca De Lorenzo, MD

Role: CONTACT

delorenzo.rebecca@hsr.it

+390226433065

Facility Contacts

Patrizia Rovere Querini, MD

Role: primary

rovere.patrizia@hsr.it

+390226433065

Patrizia Rovere Querini

Role: primary

rovere.patrizia@hsr.it

+390226433065

Other Identifiers

MED-Cli

Identifier Type: -

Identifier Source: org_study_id