|- candidate number||27548|
|- NTR Number||NTR6568|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2017|
|- Secondary IDs||NL62679.029.17 / 2017.048 ToetsingOnline / METC VUMC|
|- Public Title||MAGnesium in Chronic HemoDialysis|
|- Scientific Title||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. |
|- hypothesis||Increasing plasma magnesium concentration in hemodialysis patients by means of increasing dialysate magnesium concentration is feasible. |
|- Healt Condition(s) or Problem(s) studied||Chronic kidney disease, End-stage renal disease|
|- Inclusion criteria||- Age 18 years or above|
- Hemodialysis with regular three times weekly dialysis schedule
- Hemodialysis since at least 3 months
- Standard dialysate Mg2+ 0.50 mmol/L
- Providing informed consent
- Pre-dialysis plasma magnesium concentration not higher than 1.00 mmol/L
|- Exclusion criteria||- Intravenous magnesium supplementation (including total parenteral nutrition) in the last 2 weeks|
- Expected cessation of dialysis 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
- Regular use of a dialysate tank that results in a dialysate potassium concentration of 3.00 mmol/L or 1.00 mmol/L (or any other potassium concentration that is not 2.00 mmol/L).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2017|
|- planned closingdate||1-mrt-2019|
|- Target number of participants||53|
|- Interventions||Stepwise increase of magnesium concentration in the dialysate:|
- Week 0: continuation of standard 0.50 mmol/L dialysate magnesium
- Week 1, 2, 3, 4: dialysate magnesium 0.75 mmol/L
- Week 5, 6, 7, 8: dialysate magnesium 1.00 mmol/L if pre-dialysis plasma Mg <1.15 mmol/L in week 4; dialysate magnesium 0.75 mmol/L if pre-dialysis plasma Mg 1.15 or above in week 4
- Week 9: dialysate magnesium concentration reduction of 0.25 mmol/L (to either 0.75 mmol/L or 0.50 mmol/L)
- Week 10, 11: dialysate magnesium 0.50 mmol/L
|- Primary outcome||- The difference between plasma magnesium concentration after the long interdialytic interval in the intervention group with incremental dialysate magnesium concentration and plasma magnesium concentration in the control group with standard dialysate magnesium concentration at the end of week 8.|
- The difference in change of plasma magnesium concentration after the long interdialytic interval from baseline to the end of week 8 between the intervention group and the control group.
|- Secondary outcome||- The cumulative incidence of magnesium concentration 1.25 mmol/L or above in the intervention group and in the control group.|
- The cumulative incidence of prolonged duration of QTc (defined as >450ms in male and >460ms in female) in the intervention group and in the control group.
- The cumulative incidence of bradycardia (defined as heart rate below 60 beats per minute) in the intervention group and in the control group.
- The effect of dialysate magnesium concentration on pre-dialysis and post-dialysis plasma magnesium concentration at the dialysis after the long interdialytic interval.
- Predictive factors for the effect of dialysate magnesium concentration on pre-dialysis and post-dialysis plasma magnesium concentration at the dialysis after the long interdialytic interval.
- The difference in carotid-femoral pulse wave velocity in the intervention group and the control group in week 8, and the difference in change of pulse wave velocity from baseline to week 8 between the intervention group and the control group.
|- Timepoints||- week 0-11 plasma magnesium measurements|
- week 0, 4, 8 study visit
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| N.H.J. Leenders|
|- CONTACT for SCIENTIFIC QUERIES|| N.H.J. Leenders|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Dutch Kidney Foundation (Nierstichting Nederland) - project ID 15Op02|
|- Brief summary||Background: In observational hemodialysis cohort studies, lower serum magnesium levels are associated with overall and cardiovascular mortality. In vitro, magnesium inhibits calcification of vascular smooth muscle cells. Based on these data, we hypothesize that lower magnesium is a new risk factor for cardiovascular disease in CKD. The dialysate might be an attractive way to increase plasma dialysate concentration. |
Objective/Research questions: Determine feasibility to increase plasma dialysate magnesium concentration by means of increasing dialysate magnesium concentration.
Methods: A prospective randomized double blind standard of care controlled trial in patients on a regular 3 times weekly hemodialysis schedule. The control group continues dialysis with the standard dialysate magnesium concentration of 0.50 mmol/L. In the intervention group, the dialysate magnesium concentration is step-wise increased from 0.50 mmol/L to 0.75 mmol/L to 1.00 mmol/L, followed by a gradual decrease to the standard dialysate magnesium concentration of 0.50 mmol/L.
1. The difference between plasma magnesium concentration after the long interdialytic interval in the intervention group with incremental dialysate magnesium concentration and plasma magnesium concentration in the control group with standard dialysate magnesium concentration at the end of week 8.
2. The difference in change of plasma magnesium concentration after the long interdialytic interval from baseline to the end of week 8 between the intervention group and the control group.
Country of recruitment: The Netherlands
|- Main changes (audit trail)|
|- RECORD||14-jul-2017 - 21-okt-2017|