End-Stage Renal Disease, Hemodialysis
Conditions
Keywords
Hemodialysis, Coronary artery calcification, Adynamic bone disease, Dialysate calcium, Bone mineral density, Bone histomorphometry
Brief summary
The high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors. One of such factors proposed to contribute to the cardiovascular mortality in dialysis patient population is vascular calcification possibly resulting from disturbances of calcium-phosphate metabolism. The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or 1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone histomorphometry in hemodialysis patients.
Detailed description
Sample size calculations were based on previously reported changes in coronary artery calcification scores in hemodialysis patients during time (90% power with a two-sided, alpha error rate of 5%). Four hundred fifty-seven hemodialysis patients, taking drop-out rate into consideration, will be enrolled in this prospective-controlled study.The cases already being treated with calcium-based phosphate binder and dialysate containing 1.75 or 1.5 mmol/L calcium will be enrolled from eight hemodialysis centers.The cases will be randomized to two arms: 1. Dialysate containing 1.25 mmol/L calcium + calcium-based phosphate binder group: Dialysate calcium will be reduced from 1.75 or 1.5 mmol/L to 1.25 mmol/L in this group. Patients will use calcium-based phosphate binder according to phosphate level. 2. Dialysate containing 1.75 mmol/L calcium + calcium-based phosphate binder group (Control group): Dialysate calcium will remain or switched to 1.75 mmol/L and patients will be on calcium-based phosphate binder. The study will last for 18 months.Coronary artery calcification (Multi-slice CT), bone histomorphometry, and bone mineral density will be assessed in the beginning and at the end of the study. Coronary artery calcification and bone mineral density will be measured in all patients; bone histomorphometry will be assessed in 150 patients, 75 from each group.
Interventions
DRUGLow dialysate calcium
1.25 mmol/L dialysate calcium
DRUGhigh dialysate calcium
1.75 mmol/L dialysate calcium
Sponsors
University of Kentucky
Fresenius Medical Care North America
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 80 years * On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week * To be treated with a dialysate containing 1.75 or 1.5 mmol/L calcium * Willingness to participate in the study with a written informed consent
Exclusion criteria
* To be scheduled for living donor renal transplantation * To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease * Pregnancy or lactating * To be unable to give informed consent because of mental incompetence or a psychiatric disorder * To be on vitamin D treatment within six months of randomization or having iPTH values over target levels (\>300 pg/mL) * Hypercalcemia (Ca \>10.5 mg/dl) with use of dialysate containing 1.75 or 1.5 mmol/L calcium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of coronary artery calcification scores | eighteen months |
| Changes in bone histomorphometry analysis | eighteen months |
| Changes in bone mineral density | eighteen months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in intact PTH levels | eighteen months |
| effects of dialysate with or without glucose (e.g intradialytic hypoglycemia and hypotension, arrythmia-by Holter ECG- and changes in HbA1c, insulin) | eighteen months |
Countries
Turkey (Türkiye), United States
Outcome results
None listed