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

Prim. Priv. Doz. Dr. Daniel Cejka26 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

Dialysate bicarbonate modificationOTHER

Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Outcomes

Primary Outcomes

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.

Time frame: 6 Weeks

Secondary Outcomes

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.

Time frame: 6 Weeks

Data from ClinicalTrials.gov

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