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

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

Detailed Description
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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.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: Dialysate bicarbonate modification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional Model Description: This is a single-center, prospective, proof-of-priciple, pilot study. Bicarbonate for dialysis will be modified step-by-step from 27 mmol/l to 37 mmol/l.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |