Skip to main content
OpenTrials
Completed

NCT Number: NCT06084858

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

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dialysate bicarbonate modification

Other

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

Primary outcomes

  1. 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

  1. CPP Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prim. Priv. Doz. Dr. Daniel Cejka

Other

Registry information

Official study title

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

Acronym: D-Bic-T50-HD

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 16, 2023
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.