To assess intra- and interpatient variability of plasma Mg concentration before and after hemodialysis.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Nephropathies
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameters: Plasma Mg before and after dialysis in 6 consecutive
hemodialysis sessions, determined in duplicate.
Main endpoints: The intra-individual pre-dialysis variability and post-dialysis
(dialysis-induced) variability of plasma Mg and the interindividual variability
of pre-dialysis and post-dialysis plasma Mg.
Secondary outcome
- The difference in point-estimate of plasma Mg concentration before and after
dialysis, using a fixed standard dialysate Mg concentration, as a function of
predialysis Mg concentration.
- Factors that predict larger differences in point-estimates of plasma Mg
before and after dialysis.
Background summary
Cardiovascular disease is the leading cause of death in patients with chronic
kidney disease (CKD). Traditional risk factors account for only part of this
risk. Identification of new risk factors, might facilitate therapy changes to
improve prognosis in patients with CKD. Magnesium (Mg) has recently gained
attention. In observational studies in hemodialysis patients, lower Mg levels
were associated with overall and cardiovascular mortality. In vitro studies
showed inhibition of calcification of vascular smooth muscle cells in the
presence of Mg. Based on these data, we hypothesize that Mg is a new modifiable
risk factor for cardiovascular disease in CKD. Before proceeding to
intervention trials with clinically relevant endpoints, targeting relatively
low plasma magnesium levels in hemodialysis patients, information on
variability of plasma Mg levels in these patients is needed. Currently however
no reliable observational data are available in the literature describing the
within-subject biological variability of Mg concentrations in haemodialysis
patients before and after dialysis with a fixed concentration of Mg in the
dialysate. Information on variability is critical, to ensure safety for
individual patients when increasing plasma Mg levels, but also to enable formal
power-calculations to estimate the numbers of subjects required for future
interventional studies.
Study objective
To assess intra- and interpatient variability of plasma Mg concentration before
and after hemodialysis.
Study design
Observational single-center study.
Study burden and risks
Patient effort is minimal for this study. Blood samples (3mL each) will be
taken before and after dialysis in six consecutive hemodialysis sessions,
during a period of two weeks. The blood samples can be taken from the dialysis
circuit so no additional puncture is needed. No additional risks are involved.
There are no direct advantages for patients participating in this study. The
study might facilitate the adequate design of future trials targeting
relatively low plasma Mg.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Age *18
- Hemodialysis with regular three times weekly dialysis schedule
- Hemodialysis since at least 3 months
- Standard dialysate Mg2+ 0.5 mmol/L
- Providing informed consent
Exclusion criteria
- Age <18
- Intravenous magnesium supplementation that has been started or stopped in the last 2 weeks, or the subject currently receives non-continuous magnesium supplementation. Note: subjects receiving stable continuous intravenous magnesium supplementation including total parenteral nutrition since at least 2 weeks can be included.
- Expected cessation of dialysis treatment within 2 weeks after inclusion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57914.029.16 |