Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02399358

Enrollment

200

Registered

2015-03-26

Start date

2015-12-31

Completion date

2017-11-30

Last updated

2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Keywords

Drug induced Hyponatremia, Cyclophosphamide, Hyponatremia, Cyclophosphamide induced Hyponatremia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Argentina

Contacts

Primary ContactFernando Warley, MD

fernando.warley@hospitalitaliano.org.ar+54 9 11 61541958

Backup ContactBelen Bonella, MD

maria.bonella@hospitalitaliano.org.ar+54 9 11 21620279

Outcome results