Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

Diego Hernan Giunta, MD

Status: Unknown

Conditions: Hyponatremia

Study type: Observational

Funder types: Other

Identifiers

NCT02399358

2439 (Other Identifier)

Details and patient eligibility

About

Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Refusal to participate or to the process of informed consent.

Trial design

200 participants in 1 patient group

High-dose Cyclophosphamide

Description:

Patients requiring infusion of high-dose cyclophosphamide in the period 2015-2017 will be included. After informed consent, patients will de follow up from the infusion of cyclophosphamide to 30 days after hospital discharge.