Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hyponatremia
研究概览
简要总结
Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.
详细描述
Primary objectives
- To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more).
- Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide.
- To estimate the incidence of hyponatremia in patients undergoing high-dose cyclophosphamide.
Study design. Observational prospective cohort study of Patients after infusion of high-dose cyclophosphamide. Follow up period will be from cyclophosphamide infusion until one month after hospital discharge.
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
- •Adult patients (over 18 years) who were admitted to the Hematology / Oncology and Medical Clinic Hospital Italiano de Buenos Aires infusion of high-dose cyclophosphamide for conducting MSCH prior BMT, GATLA and HyperCVAD in the period 2015-2017.
排除标准
- •Refusal to participate or to the process of informed consent.
结局指标
主要结局
Hyponatremia
时间窗: Between 6 and 8 hours after the infusion of cyclophosphamide is performed.
Hyponatremia, measured as any value sodium after infusion and defined as positive if sodium less than 135 mEq / l (Yes / No, dichotomous categorical variable). For the incidence of hyponatremia is only included in the calculation hionatremia patients with normal sodium before infusion.
次要结局
未报告次要终点
研究者
Diego Hernan Giunta, MD
Investigator
Hospital Italiano de Buenos Aires