Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients (D-Bic-T50-HD)

Prim. Priv. Doz. Dr. Daniel Cejka

Status

Completed

Conditions

End Stage Renal Disease

Treatments

Other: Dialysate bicarbonate modification

Study type

Interventional

Funder types

Other

Identifiers

NCT06084858

D-Bic-T50-HD

Details and patient eligibility

About

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

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.