The Effects of Different Dialysate Calcium Concentration

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Different Dialysate Calcium Concentration on Mineral-bone Metabolism in Chinese Patients on Maintenance Hemodialysis

Conditions
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Mineral-bone Metabolism

Intervention / Treatment
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* Other: different dialysate calcium concentration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65, maintenance hemodialysis, dialytic vintage ≥12 months, iPTH 150-300pg/ml, serum calcium<2.5mmol/L, serum calcium<2.5mmol/L. Exclusion Criteria: Age<18 or >65 Severe acid-base disturbance History of parathyroid glands or adrenal gland combined with consumptions or malnutrition anemia due to acute bleeding or other diseases except for renal failure newly occurred bone fracture within 3 months active stage of immunological diseases using glucocorticoid or immunosuppressor combined with any disease with expect duration <2 year newly occurred acute heart failure, acute myocardial failure , acute cerebral infarction or stroke within 6 months pregnant women of women in preparation for pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DCa1.25<br>using dialysate calcium concentration 1.25 mmol/L(DCa1.25) | Other: different dialysate calcium concentration<br> <br> |
| Active Comparator: DCa1.5<br>using dialysate calcium concentration 1.5mmol/L | Other: different dialysate calcium concentration<br> <br> |
| Active Comparator: DCa1.75<br>using dialysate calcium concentration 1.75mmol/L | Other: different dialysate calcium concentration<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | incidence of death | 24months | 
| cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke) | incidence of cardio-cerebral vascular disease | 24months | 
| newly nontraumatic bone fracture | incidence of newly nontraumatic bone fracture | 24months | 
| secondary hyperparathyroidism uncontrolled by medicine | incidence of secondary hyperparathyroidism uncontrolled by medicine | 24months | 
| valvular or vascular calcification | incidence of valvular or vascular calcification | 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| admission or emergency observation | incidence of admission or emergency observation | 24months |