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| Name | Class |
|---|---|
| Fresenius AG | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - B | Active Comparator | Patients undergo treatment with intervention A (dialysate magnesium 0.75 mmol), followed by intervention B (dialysate magnesium 1.00 mmol/l) |
|
| Arm B - A | Active Comparator | Patients undergo treatment with intervention B (dialysate magnesium 1.00 mmol), followed by intervention A (dialysate magnesium 0.75 mmol/l) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A - Dialysate magnesium 0.75 | Device | Citrate-based concentrate with magnesium 0.75 mmol/l |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion predialysis magnesium in target range | Proportion of patients with a predialysis serum Mg concentration between 1,10 and 1,45mmol/L on day 15 of the intervention | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean predialysis Magnesium | Average serum predialysis total Mg on day 15 after intervention/comparator | 2 weeks |
| Mean predialysis ionized Magnesium | Average serum predialysis ionized Mg on day 15 after the intervention/comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory 1 - muscle cramps | muscle cramps | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjorn Meijers, MD, PhD | UZ Leuven | Study Chair |
| Karlien Francois, MD, PhD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Gert Meeus, MD | AZ groeninghe | Principal Investigator |
| Rogier Caluwé, MD, PhD | AZORG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Brussels Capital | 1000 | Belgium | ||
| Azorg |
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| ID | Term |
|---|---|
| D009120 | Muscle Cramp |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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multicenter, prospective, parallel group design
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Participant-blinded, open to care providers and investigators
| B - Dialysate magnesium 1.00 mmol/L | Device | Citrate-based concentrate with magnesium 1.00 mmol/l |
|
|
| 2 weeks |
| Mean postdialysis ionized Magnesium | Average serum postdialysis ionized Mg on day 15 after intervention/comparator | 2 weeks |
| Proportion low predialysis magnesium | Proportion of patients with predialysis Mg <1,05 mmol/L on day 15 of the intervention | 2 weeks |
| Proportion high predialysis magnesium | Proportion of patients with predialysis Mg >1,5 mmol/L on day 15 of the intervention | 2 weeks |
| Cardiac safety endpoint 1 | occurrance of cardiac arrythmias | 2 weeks |
| Cardiac safety endpoint 2 | Change in QTc-interval in milliseconds | 2 weeks |
| Aalst |
| Oost-Vlaanderen |
| Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| AZ groeninge | Kortrijk | West-Vlaanderen | 3621 | Belgium |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |