Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Serum Magnesium Levels

Universitaire Ziekenhuizen KU Leuven54 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dialysis; Complications

Interventions

A - Dialysate magnesium 0.75DEVICE

Citrate-based concentrate with magnesium 0.75 mmol/l

B - Dialysate magnesium 1.00 mmol/LDEVICE

Citrate-based concentrate with magnesium 1.00 mmol/l

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

UZ Brussel

Brussels, Brussels Capital, Belgium

Azorg

Aalst, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

AZ groeninge

Kortrijk, West-Vlaanderen, Belgium

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Secondary Outcomes

Mean predialysis Magnesium

Average serum predialysis total Mg on day 15 after intervention/comparator

Time frame: 2 weeks

Mean predialysis ionized Magnesium

Average serum predialysis ionized Mg on day 15 after the intervention/comparator

Time frame: 2 weeks

Mean postdialysis ionized Magnesium

Average serum postdialysis ionized Mg on day 15 after intervention/comparator

Time frame: 2 weeks

Proportion low predialysis magnesium

Proportion of patients with predialysis Mg \<1,05 mmol/L on day 15 of the intervention

Time frame: 2 weeks

Proportion high predialysis magnesium

Proportion of patients with predialysis Mg \>1,5 mmol/L on day 15 of the intervention

Time frame: 2 weeks

Cardiac safety endpoint 1

occurrance of cardiac arrythmias

Time frame: 2 weeks

Cardiac safety endpoint 2

Change in QTc-interval in milliseconds

Time frame: 2 weeks

Data from ClinicalTrials.gov

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