Higher vs. Lower Hemodialysate Magnesium for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how altering magnesium levels in dialysis fluid can benefit people with kidney failure undergoing hemodialysis. The goal is to determine if increased magnesium can reduce the risk of death and heart problems, and possibly lessen muscle cramps. Researchers believe this simple change might improve patient well-being and lower healthcare costs. Individuals on hemodialysis who experience heart issues or frequent muscle cramps might be suitable candidates for this study.
As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance patient care and outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on changing the magnesium level in the dialysis solution, so it's best to ask the trial staff for guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that increasing magnesium levels in dialysis fluid might be safe for patients. Studies suggest that patients on dialysis with higher magnesium levels in their treatment fluid could experience heart health benefits. However, this is still under investigation. Reports indicate that using fluid with low magnesium can lead to low magnesium levels in the blood, which is not ideal.
Previous research has included patients using fluid with magnesium levels similar to those in this trial. These studies did not find major safety issues. Participants using higher magnesium levels in their treatment fluid did not experience more side effects than those using lower levels. This suggests that different magnesium levels in the fluid are generally well-tolerated.
For those considering joining this study, this information may help clarify how the trial aims to measure the impact of magnesium on health outcomes.12345Why are researchers excited about this trial?
Researchers are excited about the trial comparing higher versus lower hemodialysate magnesium levels for kidney failure because it could uncover optimal magnesium levels for dialysis patients. Unlike standard dialysis treatments that don't specifically focus on magnesium levels, this approach tests whether adjusting magnesium in the dialysate can improve patient outcomes. By fine-tuning magnesium levels, there is potential to enhance heart health, bone strength, and overall well-being for those undergoing dialysis, which could be a significant advancement over current practices.
What evidence suggests that increasing magnesium in the dialysate could be effective for patients on dialysis?
This trial will compare the effects of different magnesium levels in dialysis fluid for kidney failure patients. Research has shown that increasing magnesium in the dialysis fluid might be beneficial. Studies suggest that patients with low magnesium levels face a higher risk of heart problems and muscle cramps. Raising magnesium in the dialysis fluid may reduce these risks. Some research also indicates that this adjustment could improve overall survival and decrease hospital visits due to heart issues. Overall, adjusting magnesium levels in dialysis is considered a safe and potentially beneficial approach.12367
Who Is on the Research Team?
Amit X Garg, PhD, MD
Principal Investigator
ICES, Lawson, London Health Sciences Centre
Are You a Good Fit for This Trial?
This trial is for patients undergoing in-center maintenance hemodialysis at facilities that treat at least 15 such patients. The facility's medical director must agree to use the assigned magnesium protocol throughout the study. Centers with fewer than 15 patients on conventional in-center hemodialysis are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either higher or lower dialysate magnesium concentration as part of their routine hemodialysis treatment
Follow-up
Participants are monitored for cardiovascular-related hospitalization and all-cause mortality using routinely collected data
What Are the Treatments Tested in This Trial?
Interventions
- Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L)
- Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L)
Trial Overview
The study is testing two different concentrations of magnesium in dialysate solutions used during hemodialysis: one lower (≤1.0 mEq/L) and one higher (1.5 mEq/L). It aims to see if a higher concentration can reduce deaths, heart-related hospitalizations, and muscle cramps associated with dialysis.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor
ICES
Industry Sponsor
ICES
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Citations
Magnesium in chronic kidney disease Stages 3 and 4 and ...
Twenty-five of the renal patients had been dialysed for a period of ∼23 months with a dialysis fluid containing 1.3 mEq/L (0.65 mmol/L) magnesium. Plasma ...
2.
clinicaltrial.be
clinicaltrial.be/en/details/4788?per_page=20&only_recruiting=0&only_eligible=0&only_active=0Outcomes of a Higher vs. Lower Hemodialysate ...
If the investigator is able to demonstrate that a higher dialysate magnesium concentration improves patient outcomes, this formulation can be ...
Higher vs. Lower Hemodialysate Magnesium for Kidney ...
Studies suggest that increasing magnesium levels in dialysate for hemodialysis patients may be safe and could potentially offer cardiovascular benefits. However ...
4.
ctv.veeva.com
ctv.veeva.com/study/outcomes-of-a-higher-vs-lower-hemodialysate-magnesium-concentration-dial-mag-canadaOutcomes of a Higher vs. Lower Hemodialysate Magnesium ...
Patients with low serum magnesium concentration have a higher risk of death, heart issues, muscle cramps and fractures. There are several ...
Magnesium Concentration in Dialysate: Is Higher Better?
A total of 59 patients were randomized to either standard dialysate magnesium (0.5 mmol/L; 1 mEq/L) or to a high-dialysate magnesium (1 mmol/L; 2 mEq/L) for 4 ...
6.
karger.com
karger.com/bpu/article/45/1-3/173/329522/Magnesium-in-Chronic-Kidney-Disease-Should-We-CareMagnesium in Chronic Kidney Disease: Should We Care?
Use of low-Mg dialysate (0.25 mmol/L or 0.5 mEq/L) is a risk factor for hypomagnesaemia in patients on both haemodialysis (HD) and peritoneal ...
Magnesium in Kidney Function and Disease—Implications ...
Ten studies were found in which the role of Mg and sex was evaluated in elderly patients with CKD in the last 10 years (2012–2022).
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