Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT06084858
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Sponsor:
Prim. Priv. Doz. Dr. Daniel Cejka
Organization:
Study Overview
Official Title:
Effect of Dialysate Bicarbonate Prescription on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
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:
D-Bic-T50-HD
Brief Summary:
This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.
Detailed Description:
This single-arm, proof-of-principle study will be conducted at the dialysis facility of the Ordensklinikum Linz Elisabethinen Hospital. The dialysate bicarbonate prescription will be decreased from standard of care (usually 35mmol/l) in a stepwise fashion (2 mmol/l per change) to 27 mmol/l and subsequentially increased in a stepwise fashion (2 mmol/l per change) to 37 mmol/l over the course of 6 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: