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

  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.


Sponsor: Diego Hernan Giunta, MD

Current Primary Outcome: Hyponatremia [ Time Frame: 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.


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