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Completed

NCT Number: NCT07106073

Fever In Palliative Care

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.

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Key information

Conditions

Fever Body Temperature Changes Palliative Care Pathological Conditions, Signs and Symptoms Signs and Symptoms Terminal Illness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Fatebenefratelli Sacco

Milan, Italia, 20157, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Frequency of Fever in Terminally Ill Patients

    Time frame: 48 weeks

    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

Secondary outcomes

  1. Intensity of Fever

    Time frame: 48 weeks

    Maximum temperature recorded during febrile episodes among patients who develop fever.

    Unit of Measure: Degrees Celsius (°C)

Other outcomes

  1. Duration of Fever

    Time frame: 48 weeks

    Number of consecutive days with fever for each febrile episode. Unit of Measure: Days

  2. Clinical Correlates of Fever

    Time frame: 48 weeks

    Association between fever occurrence and clinical/demographic factors including age, sex, BMI, comorbidities, Palliative Performance Scale (PPS), and Palliative Prognostic Index (PPI).

    Unit of Measure: Odds Ratios or correlation coefficients (as per analysis plan)

  3. Length of Stay in Hospice

    Time frame: 48 weeks

    Number of days each patient remained in hospice care before discharge or death. Unit of Measure: Days

  4. Etiology and Management of Fever

    Time frame: 48 weeks

    Presumed clinical cause of fever (e.g., infection, neoplastic fever) and therapeutic approach (e.g., antibiotics, antipyretics, supportive care).

    Unit of Measure: Number of patients per etiology and management category

  5. Symptom Burden at Admission

    Time frame: At admission

    Assessment of physical and psychological symptom severity at admission using the Edmonton Symptom Assessment System (ESAS). Each symptom is rated on a scale from 0 (none) to 10 (worst possible).

    Unit of Measure: ESAS scores per symptom (0-10)

  6. Palliative sedation

    Time frame: 48 weeks

    Number of patients who required palliative sedation during their hospice stay. Unit of Measure: Number of patients

  7. Patient Outcome at End of Stay

    Time frame: 48 weeks

    Status at the end of hospice stay (discharged or deceased in hospice). Unit of Measure: Number of patients per outcome category

  8. Place of Care Before Admission

    Time frame: At admission

    Care setting prior to hospice admission (e.g., home, hospital, nursing facility).

    Unit of Measure: Number of patients per care setting category

  9. Clinical and Demographic Characteristics at Admission

    Time frame: At admission

    Baseline characteristics including:

    • Age (years)
    • Sex (male/female)
    • Primary diagnosis (e.g., cancer, HIV, neurodegenerative diseases)
    • Comorbidities (as per clinical records)
    • Functional status using the Palliative Performance Scale (PPS)
    • Prognosis using the Palliative Prognostic Index (PPI) Unit of Measure: Descriptive statistics (e.g., mean, median, frequency)

Sponsors and collaborators

Lead sponsor

Stefania Cheli

Other

Registry information

Official study title

La Febbre Nelle Cure Palliative

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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