Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

December 16, 2015 updated by: Diego Hernan Giunta, MD

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

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Capital Federal
      • Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires, Peron 4190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients (Over 18 years) admitted for high-dose cyclophosphamide.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 6 and 8 hours after the infusion of cyclophosphamide is performed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diego Hernan Giunta, MD

Investigators

  • Principal Investigator: Belen Bonella, MD, Hospital Italiano de Buenos Aires
  • Principal Investigator: Victoria Otero, MD, Hospital Italiano de Buenos Aires
  • Principal Investigator: Bruno L Ferreyro, MD, Hospital Italiano de Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

March 22, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2439 (Inselspital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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