Dialysis; Complications
Conditions
Keywords
hemodialysis, dialysate, magnesium, muscle cramps
Brief summary
Individuals with ESKD and treated with hemodialysis have a high mortality risk. Associative studies suggest a relationship between serum magnesium concentration and mortality risk. The influence of magnesium concentration on mortality risk is unknown. This pilot study will explore whether altering dialysate magnesium concentration in the presence of citrate will change serum magnesium concentrations.
Detailed description
To determine if a citrate enriched, Mg 1.0 mmol/L dialysate, when compared to a Mg 0,75 mmol/L citrate enriched dialysate leads to a: * higher average serum predialysis total Mg on day 15 of the intervention * higher average serum predialysis ionized Mg on day 15 of the intervention * higher average serum postdialysis ionized Mg on day 15 of the intervention * smaller proportion of patients with serum predialysis Mg \<1,05 mmol/L on day 15 of the intervention * larger proportion of patients with serum predialysis Mg \> 1,50 mmol/L on day 15 of the intervention * larger difference in predialysis Mg on day 15 versus day one of the intervention.
Interventions
DEVICEA - Dialysate magnesium 0.75
Citrate-based concentrate with magnesium 0.75 mmol/l
DEVICEB - Dialysate magnesium 1.00 mmol/L
Citrate-based concentrate with magnesium 1.00 mmol/l
Sponsors
Universitaire Ziekenhuizen KU Leuven
Fresenius AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant-blinded, open to care providers and investigators
Intervention model description
multicenter, prospective, parallel group design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent must be obtained prior to any screening procedures 2. Clinically stable during two months prior to the study. This will be based upon clinical judgement. 3. On stable blood pressure medication 4 weeks prior to the study 4. Dialysis with a K3 dialysate 5. Adequate double-needle dialysis access (fistula or catheter) 6. Able to fill questionnaire/symptom score
Exclusion criteria
1. Predialysis calcium \<1,9mmol/L during baseline 2. Magnesium predialysis \>1,45mmol/L during baseline 3. Patient has a history of child C liver cirrhosis 4. Coronary intervention \<3 months before randomization 5. Hospitalization \<2 months before randomization 6. Uncontrolled predialysis hypertension \>160/90mmHg despite 4 antihypertensive drugs 7. Predialysis blood pressure \<90mmHg during baseline visit 8. History of dialysis access related problems \<1 month before the randomization 9. Chronic Atrial fibrillation 10. NYHA class 4 heart failure 11. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion predialysis magnesium in target range | 2 weeks | Proportion of patients with a predialysis serum Mg concentration between 1,10 and 1,45mmol/L on day 15 of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean predialysis Magnesium | 2 weeks | Average serum predialysis total Mg on day 15 after intervention/comparator |
| Mean predialysis ionized Magnesium | 2 weeks | Average serum predialysis ionized Mg on day 15 after the intervention/comparator |
| Mean postdialysis ionized Magnesium | 2 weeks | Average serum postdialysis ionized Mg on day 15 after intervention/comparator |
| Proportion low predialysis magnesium | 2 weeks | Proportion of patients with predialysis Mg \<1,05 mmol/L on day 15 of the intervention |
| Proportion high predialysis magnesium | 2 weeks | Proportion of patients with predialysis Mg \>1,5 mmol/L on day 15 of the intervention |
| Cardiac safety endpoint 1 | 2 weeks | occurrance of cardiac arrythmias |
| Cardiac safety endpoint 2 | 2 weeks | Change in QTc-interval in milliseconds |
Countries
Belgium
Contacts
STUDY_CHAIRBjorn Meijers, MD, PhD
UZ Leuven
PRINCIPAL_INVESTIGATORKarlien Francois, MD, PhD
Universitair Ziekenhuis Brussel
PRINCIPAL_INVESTIGATORGert Meeus, MD
AZ groeninghe
PRINCIPAL_INVESTIGATORRogier Caluwé, MD, PhD
AZORG
Outcome results
None listed