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

NCT06084858 | Completed

• 1 other identifier: D-Bic-T50-HD
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End Stage Renal Disease

Outcome Measures

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.

  6 Weeks

Secondary Outcomes (1)

• CPP Levels

  6 Weeks

Study Arms (1)

Dialysate Bicarbonat modification

EXPERIMENTAL

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

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

Dialysate Bicarbonat modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prim. Priv. Doz. Dr. Daniel Cejka: lead

Study Sites (1)

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Cejka, MD

  Head of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, prospective, proof-of-priciple, pilot study. Bicarbonate for dialysis will be modified step-by-step from 27 mmol/l to 37 mmol/l.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: October 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: August 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

AU (1)