Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04079582
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2019-09-03
Brief Title:
Outcomes of a Higher vs Lower Hemodialysate Magnesium Concentration Dial-Mag Canada
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Outcomes of a Higher vs Lower Hemodialysate Magnesium Concentration A Pragmatic Cluster-randomized Clinical Trial in Hemodialysis Centres
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many patients on hemodialysis have low levels of magnesium Magnesium is needed to keep the heart kidneys and other organs working properly Patients with low serum magnesium concentration have a higher risk of death heart issues muscle cramps and fractures There are several reasons why patients on dialysis have low levels of magnesium-these include poor diet medication interference and the dialysis procedure itself which leaches small amounts of magnesium from the blood during each treatment
One way to make sure that patients on dialysis are getting enough magnesium is to increase its concentration in the dialysate The investigator would like to do a randomized controlled trial to determine the effect of increasing the concentration of magnesium in the dialysate on the risk of people on dialysis dying or being admitted to the hospital due to heart issues The investigator thinks increasing the magnesium in the dialysate will help patients live longer have fewer hospitalisations related to heart disease and patients may also experience less cramping associated with dialysis
This simple adjustment to the dialysis procedure can be done at little cost and may even reduce overall healthcare costs If the investigator can show that increasing magnesium in the dialysate improves patients health then it could become the standard of care for all patients on dialysis
One way to make sure that patients on dialysis are getting enough magnesium is to increase its concentration in the dialysate The investigator would like to do a randomized controlled trial to determine the effect of increasing the concentration of magnesium in the dialysate on the risk of people on dialysis dying or being admitted to the hospital due to heart issues The investigator thinks increasing the magnesium in the dialysate will help patients live longer have fewer hospitalisations related to heart disease and patients may also experience less cramping associated with dialysis
This simple adjustment to the dialysis procedure can be done at little cost and may even reduce overall healthcare costs If the investigator can show that increasing magnesium in the dialysate improves patients health then it could become the standard of care for all patients on dialysis
Detailed Description:
1 Statement of the health problem or issue
In end-stage kidney disease dialysis is needed to remove toxins and electrolytes that would otherwise accumulate in a patients blood The fluid used in dialysis the dialysate contains magnesium and the lower the concentration of dialysate magnesium the more magnesium is removed from a patients body during dialysis Understanding the optimal amount of magnesium to include in the dialysate is crucial as magnesium regulates more than 300 enzymes in the body and is vital to heart muscle and bone health
In Canada the dialysate is prepared by central suppliers and contains magnesium in concentrations of 038 05 or 075 mmolL In the absence of clinical trial evidence there is no consensus on what magnesium concentration is best and all 3 concentrations are used today in Canadian hemodialysis centres
2 Objective of the project
In outpatients receiving conventional hemodialysis to determine if providing a higher versus lower dialysate magnesium concentration 075 vs 05 mmolL as a centre policy alters outcomes important to patients and their providers
3 Outline
This is a pragmatic two-arm parallel-group cluster-randomized open-label multicentre comparative-effectiveness trial embedded into routine care in hemodialysis centres in Canada Centres have been randomized to and are receiving a dialysate magnesium concentration of 075 mmolL or 05 mmolL in the intervention and control groups respectively Patients receiving maintenance hemodialysis at these centres will be followed for study outcomes during the trial follow-up period
The trial is highly pragmatic to facilitate high intervention adherence and extensive uptake of the findings pragmatic features include i broad eligibility criteria and a large representative sample of hemodialysis centres and patients ii intervention implementation within routine clinical care delivered by dialysis unit personnel rather than researchers iii follow-up of patient outcomes using routinely collected data sources iv an intent-to-treat analysis using all available data and v outcomes highly relevant to patients
4 What is uniqueinnovative about the project
The investigator usually needs to study a large number of patients in a clinical trial to reliably understand the effects of a treatment Normally a study with 15000 patients would cost more than 15 million dollars to conduct however this study will provide a reliable answer to the question being asked and cost less than 4 million This is because the majority of data is already being collected by the healthcare system For example when a patient is hospitalized for a heart attack or stroke this information is recorded in a secure healthcare database The investigator will be able to analyze these healthcare data at the end of the study and link patient outcomes to the type of dialysis treatment received ie treatment or control This innovative study design means that the study will be much larger but cost much less than a traditional clinical trial
This pragmatic trial includes all patients who receive chronic in-centre hemodialysis patients in participating centres High-risk patients with multiple comorbidities including cognitive impairments or disabilities who are often excluded from trials because of their high-risk status are eligible for participation in the Dialysate Magnesium trial By including patients from a variety of medical ethnic geographic and socioeconomic backgrounds the results of the trial should be broadly generalizable
5 What is the impact of the proposed research
For patients with severe kidney failure 10000 in Ontario and 2 million worldwide hemodialysis provides a life-saving treatment option however a tragic 20-40 of patients die within one year of starting hemodialysis The dialysate is a critical component of hemodialysis yet little evidence is available to guide its optimal formulation Dialysate magnesium in particular has received little scientific attention until recently with new research suggesting that a higher dialysate magnesium concentration may benefit patients Outcomes that may be improved include mortality cardiovascular outcomes and muscle cramps
While it is possible to raise the concentration of serum magnesium through oral supplements using dialysis to do this is simpler and safer It has no additional cost does not add to a patients pill burden is not dependent on an adherent patient taking their pills and avoids the gastrointestinal side effects of oral magnesium supplements
If the investigator is able to demonstrate that a higher dialysate magnesium concentration improves patient outcomes this formulation can be readily adopted to improve the care of 2 million patients receiving hemodialysis worldwide
In end-stage kidney disease dialysis is needed to remove toxins and electrolytes that would otherwise accumulate in a patients blood The fluid used in dialysis the dialysate contains magnesium and the lower the concentration of dialysate magnesium the more magnesium is removed from a patients body during dialysis Understanding the optimal amount of magnesium to include in the dialysate is crucial as magnesium regulates more than 300 enzymes in the body and is vital to heart muscle and bone health
In Canada the dialysate is prepared by central suppliers and contains magnesium in concentrations of 038 05 or 075 mmolL In the absence of clinical trial evidence there is no consensus on what magnesium concentration is best and all 3 concentrations are used today in Canadian hemodialysis centres
2 Objective of the project
In outpatients receiving conventional hemodialysis to determine if providing a higher versus lower dialysate magnesium concentration 075 vs 05 mmolL as a centre policy alters outcomes important to patients and their providers
3 Outline
This is a pragmatic two-arm parallel-group cluster-randomized open-label multicentre comparative-effectiveness trial embedded into routine care in hemodialysis centres in Canada Centres have been randomized to and are receiving a dialysate magnesium concentration of 075 mmolL or 05 mmolL in the intervention and control groups respectively Patients receiving maintenance hemodialysis at these centres will be followed for study outcomes during the trial follow-up period
The trial is highly pragmatic to facilitate high intervention adherence and extensive uptake of the findings pragmatic features include i broad eligibility criteria and a large representative sample of hemodialysis centres and patients ii intervention implementation within routine clinical care delivered by dialysis unit personnel rather than researchers iii follow-up of patient outcomes using routinely collected data sources iv an intent-to-treat analysis using all available data and v outcomes highly relevant to patients
4 What is uniqueinnovative about the project
The investigator usually needs to study a large number of patients in a clinical trial to reliably understand the effects of a treatment Normally a study with 15000 patients would cost more than 15 million dollars to conduct however this study will provide a reliable answer to the question being asked and cost less than 4 million This is because the majority of data is already being collected by the healthcare system For example when a patient is hospitalized for a heart attack or stroke this information is recorded in a secure healthcare database The investigator will be able to analyze these healthcare data at the end of the study and link patient outcomes to the type of dialysis treatment received ie treatment or control This innovative study design means that the study will be much larger but cost much less than a traditional clinical trial
This pragmatic trial includes all patients who receive chronic in-centre hemodialysis patients in participating centres High-risk patients with multiple comorbidities including cognitive impairments or disabilities who are often excluded from trials because of their high-risk status are eligible for participation in the Dialysate Magnesium trial By including patients from a variety of medical ethnic geographic and socioeconomic backgrounds the results of the trial should be broadly generalizable
5 What is the impact of the proposed research
For patients with severe kidney failure 10000 in Ontario and 2 million worldwide hemodialysis provides a life-saving treatment option however a tragic 20-40 of patients die within one year of starting hemodialysis The dialysate is a critical component of hemodialysis yet little evidence is available to guide its optimal formulation Dialysate magnesium in particular has received little scientific attention until recently with new research suggesting that a higher dialysate magnesium concentration may benefit patients Outcomes that may be improved include mortality cardiovascular outcomes and muscle cramps
While it is possible to raise the concentration of serum magnesium through oral supplements using dialysis to do this is simpler and safer It has no additional cost does not add to a patients pill burden is not dependent on an adherent patient taking their pills and avoids the gastrointestinal side effects of oral magnesium supplements
If the investigator is able to demonstrate that a higher dialysate magnesium concentration improves patient outcomes this formulation can be readily adopted to improve the care of 2 million patients receiving hemodialysis worldwide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None