Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

NCT02399358 | Unknown

• 1 other identifier: 2439
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyponatremia

Keywords

Drug induced Hyponatremia; Cyclophosphamide; Hyponatremia; Cyclophosphamide induced Hyponatremia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Diego Hernan Giunta, MD: lead

Study Sites (1)

Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Fernando Warley, MD

  Hospital Italiano de Buenos Aires

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Warley, MD

CONTACT

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

Belen Bonella, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 22, 2015
• First Posted: March 26, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

AR (1)