Clinical Trial: Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study
Brief Summary: Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.
Detailed Summary:
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.
Sponsor: Diego Hernan Giunta, MD
Current Primary Outcome: Hyponatremia [ Time Frame: Between 6 and 8 hours after the infusion of cyclophosphamide is performed. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hospital Italiano de Buenos Aires
Dates:
Date Received: March 22, 2015
Date Started: December 2015
Date Completion: November 2017
Last Updated: December 16, 2015
Last Verified: December 2015