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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hemodialysis Frequency and the Calcification Propensity of Serum

NCT01975025

Hemodialysis Anuria

COMPLETED NA

Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

NCT01574157

Chronic Renal Insufficiency Diabetes Mellitus

COMPLETED NA

Effect of Probiotic Supplementation on Renal Function, Vascular Calcification and Alterations in Bone Mineral Metabolism in Patients With Chronic Kidney Disease

NCT07260682

Chronic Kidney Disease (Stages 3b-5)

COMPLETED NA

Calcium Concentration in Bicarbonate Hemodialysis (HD)

NCT01353170

Calcium Mass Balances and Serum Calcium Profiling in hd Patients

COMPLETED NA

A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients

NCT03795558

End Stage Renal Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dialysate Bicarbonat modification

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

Group Type EXPERIMENTAL

Dialysate bicarbonate modification

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dialysate bicarbonate modification

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No