An interventional study of Low dialysate calcium and high dialysate calcium in End-Stage Renal Disease and Hemodialysis, sponsored by Ege University. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-08-04.
Sponsored by Ege University · Not applicable, Interventional, and Treatment
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.
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:
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 457 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
high dialysate calcium
Drug: high dialysate calcium
low dialysate calcium
Drug: Low dialysate calcium
1.25 mmol/L dialysate calcium
1.75 mmol/L dialysate calcium
Progression of coronary artery calcification scores
Time frame: eighteen months
Changes in bone histomorphometry analysis
Time frame: eighteen months
Changes in bone mineral density
Time frame: eighteen months
Changes in intact PTH levels
Time frame: eighteen months
effects of dialysate with or without glucose (e.g intradialytic hypoglycemia and hypotension, arrythmia-by Holter ECG- and changes in HbA1c, insulin)
Time frame: eighteen months
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Ege University