Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

Recruiting

• Conditions: Immunological Disease; Pregnancy Disease; Chronic Disease; Cardiovascular Diseases; Metabolic Syndrome; Critical Illness; Respiratory Disease; Infectious Disease
• Interventions: Other: Inpatient or Outpatient visit

• Registration Number: NCT05780099
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2022-06-24
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-03-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2031-09-10
• Study Completion: 2032-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Inpatient or Outpatient visit	patients treated at internal medicine wards

Primary Outcome Measures

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

Trial Locations

Locations (2)

Ospedale San Raffaele; 🇮🇹 Milan, Italy

San Raffaele Hospital; 🇮🇹 Milan, Italy