Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics (MED-Cli)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Critical Illness; Metabolic Syndrome; Chronic Disease; Infectious Disease; Respiratory Disease; Pregnancy Disease; Immunological Disease
• Intervention / Treatment: Other: Inpatient or Outpatient visit

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.

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: Patrizia Rovere Querini, PhD, MD; Phone Number: +390226436095; Email: rovere.patrizia@hsr.it
• Study Contact Backup: Name: Rebecca De Lorenzo, MD; Phone Number: +390226433065; Email: delorenzo.rebecca@hsr.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Ospedale San Raffaele
    • Contact: Patrizia Rovere Querini, MD; Phone Number: +390226433065; Email: rovere.patrizia@hsr.it
  • Milan, Italy
    • Recruiting
    • San Raffaele Hospital
    • Contact: Patrizia Rovere Querini; Phone Number: +390226433065; Email: rovere.patrizia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in outpatient, inpatient or day hospital setting of internal medicine units at San Raffaele Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; patients treated at internal medicine wards	Other: Inpatient or Outpatient visit; Patients will be seen and treated at the clinics like in the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with severe disease	Identify demographic, clinical, laboratory and radiological markers of disease severity and activity	The following variables will be collected during patient enrollment

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Estimated): September 10, 2031
• Study Completion (Estimated): September 10, 2032

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Infections; Communicable Diseases; Metabolic Syndrome; Chronic Disease; Critical Illness; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: MED-Cli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No