Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum (BicMag)

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: End Stage Renal Failure on Dialysis; Vascular Calcification

Treatments: Device: Magnesium; Device: Bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT02621762

293_15

Details and patient eligibility

About

The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.

Enrollment: 12 patients

Sex: All

Ages: 18 to 111 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female hemodialysis patients ≥ 18 years of age
• Negative pregnancy test of female patients in child-bearing age
• The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
• Start of chronic hemodialysis treatment ≥ 3 months ago
• HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
• Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
• T50 ≥ 200 minutes.

Exclusion criteria

• Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
• History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

12 participants in 2 patient groups

Mg first

Experimental group

Description:

Receives MgCl2 first, MgCl2 and Bicarbonate in second phase

Treatment:

Device: Magnesium

Device: Bicarbonate

Bicarbonate first

Experimental group

Description:

Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase

Treatment:

Device: Magnesium

Device: Bicarbonate