Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT02399358
Status:
UNKNOWN
Last Update Posted:
2015-12-17
First Post:
2015-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide
Sponsor:
Diego Hernan Giunta, MD
Organization:
Study Overview
Official Title:
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: