La Febbre Nelle Cure Palliative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Frequency of Fever in Terminally Ill Patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients;
- •Age ≥ 18 years;
- •Terminally ill patients with an estimated life expectancy between 24 hours and 3 months;
- •Signed informed consent.
排除标准
- •Patients under 18 years of age;
- •Terminally ill patients with a life expectancy < 24 hours
- •Non-terminal patients admitted for respite care.
结局指标
主要结局
Frequency of Fever in Terminally Ill Patients
时间窗: 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
次要结局
- Intensity of Fever(48 weeks)
研究者
Stefania Cheli
Study coordinator
ASST Fatebenefratelli Sacco