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

Not Applicable

Completed

• Conditions: End Stage Renal Failure on Dialysis; Vascular Calcification
• Interventions: Device: Magnesium; Device: Bicarbonate

• Registration Number: NCT02621762
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-26
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bicarbonate first	Bicarbonate	Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Bicarbonate first	Magnesium	Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Mg first	Magnesium	Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
Mg first	Bicarbonate	Receives MgCl2 first, MgCl2 and Bicarbonate in second phase

Primary Outcome Measures

Name	Time	Method
Effect of treatment on serum calcification propensity, measured by T50	7 weeks	T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	7 weeks

Trial Locations

Locations (1)

University Hospital Bern Inselspital; 🇨🇭 Bern, BE, Switzerland