MAGnesium In Chronic HemoDialysis; A clinical trial assessing the feasibility of increasing plasma magnesium concentrations by means of increasing dialysate magnesium concentrations in chronic hemodialysis patients.
- Conditions
- endstage renal diseasekidney disease100822061002914910003216
- Registration Number
- NL-OMON48731
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 53
- Age 18 or above
- Hemodialysis with regular three times weekly dialysis schedule
- Hemodialysis since at least 3 months
- Standard dialysate Mg2+ concentration 0.50 mmol/L
- Providing informed consent
- Pre-dialysis plasma magnesium concentration 1.00 mmol/L or below
- Intravenous magnesium supplementation (including total parenteral nutrition)
in the last 2 weeks
- Expected cessation of hemodialysis treatment within three months after
inclusion or expected permanent or temporary dialysis center switch to a center
not participating in the trial within three months after inclusion.
- Prolongation of QTc interval: male >450ms or female >460ms on baseline ECG
- Bradycardia: heart rate below 60 beats per minute on baseline ECG
- Chronic arrythmia or cardiac conduction disorder other than atrial
fibrillation or ventricular extrasystole that poses the patient at risk at the
discretion of the treating physician.
- Change of protonpumpinhibitor prescription in the last 2 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- The difference between plasma magnesium concentration in the intervention<br /><br>group and plasma magnesium concentration in the control group after the long<br /><br>interdialytic interval at the end of week 8.<br /><br>- The difference in change of plasma magnesium concentration after the long<br /><br>interdialytic interval from baseline to the end of week 8 between the<br /><br>intervention and the control group.</p><br>
- Secondary Outcome Measures
Name Time Method