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Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

NCT ID: NCT02399358

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyponatremia

Keywords

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Drug induced Hyponatremia Cyclophosphamide Hyponatremia Cyclophosphamide induced Hyponatremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High-dose Cyclophosphamide

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diego Hernan Giunta, MD

OTHER

Sponsor Role lead

Responsible Party

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Diego Hernan Giunta, MD

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fernando Warley, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Belen Bonella, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Victoria Otero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Bruno L Ferreyro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

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Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Countries

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Argentina

Central Contacts

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Fernando Warley, MD

Role: CONTACT

Phone: +54 9 11 61541958

Email: [email protected]

Belen Bonella, MD

Role: CONTACT

Phone: +54 9 11 21620279

Email: [email protected]

Facility Contacts

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Diego H Giunta, MD

Role: primary

Cristina M Elizondo, MD

Role: backup

Other Identifiers

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2439

Identifier Type: -

Identifier Source: org_study_id