A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia Secondary to SIADH in Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Change in serum [Na+]
研究概览
简要总结
This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. The purpose of this NIS is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to keep under control serum [Na+] and the guidelines for the management of this population in Italy.
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
- •Age >= 18 years;
- •Male or female patients with a cytologically or histologically documented cancer diagnosis;
- •Moderate to severe hyponatremia: Na+ level cut off: [Na+] < 130 mmol/L;
- •Physician diagnosed Moderate to severe hyponatremia secondary to SIADH (clinical or laboratory determined as per normal routine practice of treating physician);
- •No use of diuretic agents within the week prior to evaluation;
- •Willingness to participate in the study; subjects must give their written consent to participate.
排除标准
- •Use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction;
- •Subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia;
- •Life expectancy is lower than 3 months.
结局指标
主要结局
Change in serum [Na+]
时间窗: 1 month and 6 months
Change in serum \[Na+\] from the baseline visit to the end of the first month or sixth month of the observational period or until earlier discontinuation from the study
次要结局
- EORTC QLQ-C30 to measure quality of life(From baseline up to 6 months)
- ECOG PS to assess progress of the disease(From baseline up to 6 months)
- Time to chemotherapy (days)(Longitudinal (up to 6 months))
- Survival status (%)(6 months)
- Measure of cognitive impairment: mini-mental state examination (MMSE)(From baseline up to 6 months)
- EQ-5D to measure quality of life(From baseline up to 6 months)
- Length of stay (days)(Longitudinal (up to 6 months))
- Readmission (number of readmissions)(Longitudinal (up to 6 months))