Effect of Dialysate Bicarbonate Prescription on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Prim. Priv. Doz. Dr. Daniel Cejka
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- T50-Laboratory Test for measuring calcification
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Prim. Priv. Doz. Dr. Daniel Cejka
Principal Investigator
Elisabethinen Hospital
Eligibility 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,
- •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.
Outcomes
Primary Outcomes
T50-Laboratory Test for measuring calcification
Time Frame: 6 Weeks
The intra-individual difference of T50-times between low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription.
Secondary Outcomes
- CPP Levels(6 Weeks)