BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients

ConditionEnd Stage Renal Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorElisabethinen Hospital

About this trial

The BicMag study is a prospective, randomized, controlled cross-over study that aims to examine the potential additive effect of a dialysate enriched with both bicarbonate and magnesium on mineral buffering capacity in the blood of chronic hemodialysis patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Prevalent patients (≥ 3 months) treated with thrice weekly hemodialysis or hemodiafiltration

Dialysate calcium of 1.25 mmol/l

Disqualifiers

Inability to provide informed consent

Currently participating in another investigational device or drug study or non-interventional study

Dialysate calcium other than 1.25 mmol/l

Parathyroidectomy planned during the study

Trial design

Design model

Sequential

Treatments tested in this trial

D-Standard
Other intervention
Center's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium
D-Bic
Other intervention
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium held at 0.5 mmol/L
D-Mag
Other intervention
Dialysate magnesium increased to 1.0 mmol/L; dialysate bicarbonate held at 32 mmol/L
D-BicMag
Other intervention
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium increased to 1.0 mmol/L

Treatment groups

91 Participants

are divided into 1 treatment group

Group A: dialysate composition adjustmentExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Calciprotein crystallization time (T50) as a measure of mineral buffering capacity

Intra-individual difference in T50 between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)

Time frame

3 weeks (per study phase)

Secondary outcomes

Endogenous calciprotein particle (CPP) levels

Intra-individual difference in endogenous calciprotein particle levels between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)

Time frame

3 weeks (per study phase)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elisabethinen Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: