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

Not Applicable

Completed

• Conditions: End Stage Renal Disease

• Registration Number: NCT06084858
• Lead Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka

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 Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Primary Completion: 2023-11-30
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
CPP Levels	6 Weeks	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.

Trial Locations

Locations (1)

Ordensklinikum Linz GmbH Elisabethinen; 🇦🇹 Linz, Upper Austria, Austria