An interventional study of different dialysate calcium concentration in Mineral-bone Metabolism, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-30.
Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment
The investigators enrolled 90 patients on maintenance hemodialysis with dialytic vintage ≥12 months, iPTH 150-300pg/ml and serum calcium\<2.5mmol/L. Patients were randomized to three groups with different dialysate calcium concentration , 1.25 mmol/L(DCa1.25), 1.5mmol/L(DCa1.5) and 1.75 mmol/L(DCa1.75) for 24 months respectively. Hemodialysis was performed for 4 hours three times weekly. Serum total calcium(tCa), ionized calcium(iCa),intact parathyroid hormone(iPTH)and phosphorus (P) levels were recorded before and after the study and single dialysis session in every patient. iCa and P levels were measured in spent dialysate.Bone density, bone-specific alkaline phosphatase(BAP), osteoprotegerin(OPG)、β-crosslaps、total Procollagen Type I Intact Propeptide (P1NP)and vascular calcification were measured in every patient periodically. vascular calcification including aortic arch calcification, abdominal aorta calcification and coronary artery calcification were measured by chest radiography, lateral lumbar radiographs and coronary artery computer tomography (CT) respectively. The primary endpoints included death, cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke), newly nontraumatic bone fracture, secondary parathyroidism uncontrolled by medicine and valvular or vascular calcification. The secondary endpoint were admission or emergency observation.
Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
using dialysate calcium concentration 1.25 mmol/L(DCa1.25)
Other: different dialysate calcium concentration
using dialysate calcium concentration 1.5mmol/L
Other: different dialysate calcium concentration
using dialysate calcium concentration 1.75mmol/L
Other: different dialysate calcium concentration
death
incidence of death
Time frame: 24months
cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke)
incidence of cardio-cerebral vascular disease
Time frame: 24months
newly nontraumatic bone fracture
incidence of newly nontraumatic bone fracture
Time frame: 24months
secondary hyperparathyroidism uncontrolled by medicine
incidence of secondary hyperparathyroidism uncontrolled by medicine
Time frame: 24months
valvular or vascular calcification
incidence of valvular or vascular calcification
Time frame: 24months
admission or emergency observation
incidence of admission or emergency observation
Time frame: 24months
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital