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NCT02399358 Clinical Trial

Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

Hyponatremia Clinical Trial

Official title:
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02399358
Other study ID # 2439
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 22, 2015
Last updated December 16, 2015
Start date December 2015
Est. completion date November 2017

Study information
Verified date December 2015
Source Hospital Italiano de Buenos Aires
Contact Fernando Warley, MD
Phone +54 9 11 61541958
Email fernando.warley@hospitalitaliano.org.ar
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date November 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Hospital Italiano de Buenos Aires, Peron 4190 Ciudad Autonoma de Buenos Aires Capital Federal

Sponsors (1)
Lead Sponsor Collaborator
Diego Hernan Giunta, MD

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hyponatremia 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. Between 6 and 8 hours after the infusion of cyclophosphamide is performed. Yes
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