The Effects of Different Dialysate Calcium Concentration

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Status

Sponsorzy

Beijing Friendship Hospital

BADANIE KLINICZNE: NCT01839383

BioSeek: nct01839383

Słowa kluczowe

Abstrakcyjny

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.

Daktyle

Ostatnia weryfikacja:	03/31/2013
Pierwsze przesłane:	04/21/2013
Szacowana liczba przesłanych rejestracji:	04/21/2013
Wysłany pierwszy:	04/23/2013
Ostatnia aktualizacja przesłana:	04/28/2013
Ostatnia opublikowana aktualizacja:	04/29/2013
Rzeczywista data rozpoczęcia badania:	05/31/2013
Szacowana data zakończenia podstawowej działalności:	05/31/2015

Stan lub choroba

Mineral-bone Metabolism

Interwencja / leczenie

Other: different dialysate calcium concentration

Faza

Grupy ramion

Ramię	Interwencja / leczenie
Active Comparator: DCa1.25 using dialysate calcium concentration 1.25 mmol/L(DCa1.25)
Active Comparator: DCa1.5 using dialysate calcium concentration 1.5mmol/L
Active Comparator: DCa1.75 using dialysate calcium concentration 1.75mmol/L

Kryteria kwalifikacji

Wiek kwalifikujący się do nauki	18 Years Do 18 Years
Płeć kwalifikująca się do nauki	All
Przyjmuje zdrowych wolontariuszy	tak
Kryteria	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

Wynik

Podstawowe miary wyników

1. death [24months]

incidence of death

2. cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke) [24months]

incidence of cardio-cerebral vascular disease

3. newly nontraumatic bone fracture [24months]

incidence of newly nontraumatic bone fracture

4. secondary hyperparathyroidism uncontrolled by medicine [24months]

incidence of secondary hyperparathyroidism uncontrolled by medicine

5. valvular or vascular calcification [24months]

incidence of valvular or vascular calcification

Miary wyników wtórnych

1. admission or emergency observation [24months]

incidence of admission or emergency observation

The Effects of Different Dialysate Calcium Concentration

Słowa kluczowe

phosphatase

zawał

udar mózgu

niewydolność serca

zawał mięśnia sercowego

alkaline phosphatase

hemodializa