Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide
- Conditions
- Hyponatremia
- Registration Number
- NCT02399358
- Lead Sponsor
- Diego Hernan Giunta, MD
- Brief Summary
Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.
- Detailed Description
Primary objectives
1. To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more).
2. Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide.
3. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- Refusal to participate or to the process of informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hyponatremia 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Italiano de Buenos Aires, Peron 4190
🇦🇷Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina