D-Bic-T50-HD: Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Study Details
Study Description
Brief Summary
This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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,
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Prim. Priv. Doz. Dr. Daniel Cejka
Investigators
- Principal Investigator: Daniel Cejka, MD, Head of Nephrology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D-Bic-T50-HD