Fever In Palliative Care

NCT07106073 | Completed

• 1 other identifier: La febbre
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the frequency and characteristics of fever in terminally ill adult patients admitted to the Infectious Diseases Hospice at Luigi Sacco Hospital in Milan. The main questions it aims to answer are:

• How often does fever occur in terminally ill patients during hospice care?
• What are the typical features of fever in this population in terms of intensity, duration, possible causes, and treatment strategies?
• Is there any correlation between the occurrence of fever and patients' clinical characteristics, such as age, sex, BMI, comorbidities, and palliative prognostic scores (PPS and PPI)? Participants will be adult patients (≥18 years) with a life expectancy of more than 24 hours and less than 3 months. During their stay, the following data will be collected:
• Presence and characteristics of fever (temperature, duration, treatment, suspected cause)
• Clinical and demographic information (e.g., age, sex, BMI, comorbidities, performance status)
• Details on hospitalization (e.g., symptom burden, need for palliative sedation, outcome) The study will enroll approximately 250 patients consecutively over a 48-week period. No additional procedures or treatments beyond standard clinical care will be required.

Conditions

Fever; Palliative Care; Terminal Illness

Keywords

Fever; Palliative Care; Hospice Care; Terminally ill patients; Infectious Diseases Hospice

Outcome Measures

Primary Outcomes (1)

• Frequency of Fever in Terminally Ill Patients

  Number of patients who develop at least one febrile episode (defined as body temperature \>37.5°C) during their stay in the hospice. Unit of Measure: Number of patients

  48 weeks

Secondary Outcomes (1)

• Intensity of Fever

  48 weeks

Other Outcomes (9)

• Duration of Fever

  48 weeks

• Clinical Correlates of Fever

  48 weeks

• Length of Stay in Hospice

  48 weeks

Interventions

Collection of demographic, anthropometric and clinical data. OTHER

Data collected is: * demographic data: age, sex; * anthropometric data: weight, height, body mass index; * clinical data: * Palliative Performance Scale; * Palliative Prognostic Index; * comorbidities; * therapy; * presence of medical devices; * presence of pressure injuries; * time on waiting list; * place of care; * primary diagnosis; * length of stay; * symptom burden at admission (Edmonton Symptom Assessment System); * onset of fever and its characteristics (duration, intensity, treatment, etiology); * need for sedation (duration, refractory symptom(s)); * outcome.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Hospice of Infectious Diseases at Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy. The study population includes adult terminally ill patients admitted for end-of-life care.

You may qualify if:

• Male and female patients;
• Age ≥ 18 years;
• Terminally ill patients with an estimated life expectancy between 24 hours and 3 months;
• Signed informed consent.

You may not qualify if:

• Patients under 18 years of age;
• Terminally ill patients with a life expectancy \< 24 hours
• Non-terminal patients admitted for respite care.

Sponsors & Collaborators

• Stefania Cheli: lead

Study Sites (1)

ASST Fatebenefratelli Sacco

Milan, Italia, 20157, Italy

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 6, 2025
• Study Start: March 27, 2025
• Primary Completion: June 27, 2025
• Study Completion: July 22, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)