Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients (D-Bic-T50-HD)

Effect of Dialysate Bicarbonate Prescription on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients

This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: Dialysate bicarbonate modification

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexandra Dumfarth, PMSc; Phone Number: 4302 00437327676; Email: alexandra.dumfarth@ordensklinikum.at
• Study Contact Backup: Name: Daniel Cejka, MD; Phone Number: 4300 00437327676; Email: daniel.cejka@ordensklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥18 years
• chronic (≥3 months) treatment with hemodialysis or hemodiafiltration
• stable clinical condition

Exclusion Criteria:

• inability to provide informed consent
• dialysis treatment less than thrice weekly
• morbid obesity (body mass index >40 kg/m2)
• chronic inflammation (C reactive protein >10 mg/dL, reference: <0.5 g/dL)
• current immunosuppressive medication,
• severe chronic obstructive pulmonary disease (COPD stage III or IV)
• history of severe hypercapnia or hypoxemia
• overt congestive heart failure
• history of severe hypokalemia (<3.0 mmol/l) or hyperkalemia (>6.5 mmol/L) within 3 months prior to study inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dialysate Bicarbonat modification; Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion	Other: Dialysate bicarbonate modification; Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T50-Laboratory Test for measuring calcification	The intra-individual difference of T50-times between low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription.	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPP Levels	The difference in intra-dialytic change in CPP levels with low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription, while the inter-dialytic differences in CPP levels with low and high dialysate bicarbonate prescriptions will be tertiary endpoints.	6 Weeks

Collaborators and Investigators

• Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka
• Investigators: Principal Investigator: Daniel Cejka, MD, Head of Nephrology

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: D-Bic-T50-HD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No