Fever In Palliative Care

NCT ID: NCT07106073

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-27
• Study Completion Date: 2025-07-22

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.

Detailed Description

Fever is a common clinical finding in palliative care, but its prevalence, causes, and management in terminally ill patients remain poorly documented. Existing studies report highly variable frequencies of fever near the end of life, ranging from 3% to 24%, depending on the population and setting. In this context, understanding the patterns and implications of fever in hospice patients is critical to improve symptom management and guide clinical decision-making.

This prospective, non-profit, single-center cohort study aims to collect real-world data on the presence of fever in a terminal population admitted to the Infectious Diseases Hospice at Luigi Sacco Hospital in Milan. The study will prospectively collect clinical, demographic, and treatment-related variables over a continuous 48-week period, without any deviation from routine clinical practice. By examining associations with prognostic indices, comorbidities, and symptom burden, the study also seeks to clarify whether fever represents a relevant marker of disease trajectory or end-of-life decline.

Data will be analyzed in aggregated, de-identified form using both descriptive and inferential statistics. This study is expected to contribute to filling a knowledge gap in palliative care literature and may help develop evidence-based guidance for the diagnostic and therapeutic management of fever in hospice settings.

Conditions

Fever; Palliative Care; Terminal Illness

Study Design

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

Interventions

Collection of demographic, anthropometric and clinical data.

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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

Sponsors

Stefania Cheli

OTHER

Sponsor Role: lead

Responsible Party

Stefania Cheli

Study coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

ASST Fatebenefratelli Sacco

Milan, Italia, Italy

Countries

Italy

Other Identifiers

La febbre

Identifier Type: -

Identifier Source: org_study_id