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CompletedNCT06084858D-Bic-T50-HDUpdated Aug 29, 2024

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

An interventional study of Dialysate bicarbonate modification in End Stage Renal Disease, sponsored by Prim. Priv. Doz. Dr. Daniel Cejka. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by Prim. Priv. Doz. Dr. Daniel Cejka · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • End Stage Renal Disease
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 26 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Prim. Priv. Doz. Dr. Daniel Cejka is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age ≥18 years
  • chronic (≥3 months) treatment with hemodialysis or hemodiafiltration
  • stable clinical condition

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • 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

Interventions

  • OtherDialysate bicarbonate modification

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • Ordensklinikum Linz GmbH Elisabethinen
    Linz, Upper Austria 4020, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06084858
Lead sponsor
Prim. Priv. Doz. Dr. Daniel Cejka
Responsible party
Prim. Priv. Doz. Dr. Daniel Cejka (Principal Investigator, Elisabethinen Hospital) — Sponsor-investigator
First posted
Oct 16, 2023
Start date
Oct 1, 2023
Primary completion
Nov 30, 2023
Completion
Aug 1, 2024
Last update
Aug 29, 2024

Study contacts

Daniel Cejka, MD
principal investigator · Head of Nephrology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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