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The Effects of Different Dialysate Calcium Concentration

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Beijing Friendship Hospital

Ключови думи

Резюме

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.

Дати

Последна проверка: 03/31/2013
Първо изпратено: 04/21/2013
Очаквано записване подадено: 04/21/2013
Първо публикувано: 04/23/2013
Изпратена последна актуализация: 04/28/2013
Последна актуализация публикувана: 04/29/2013
Действителна начална дата на проучването: 05/31/2013
Приблизителна дата на първично завършване: 05/31/2015

Състояние или заболяване

Mineral-bone Metabolism

Интервенция / лечение

Other: different dialysate calcium concentration

Фаза

-

Групи за ръце

ArmИнтервенция / лечение
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

Критерии за допустимост

Възрасти, отговарящи на условията за проучване 18 Years Да се 18 Years
Полове, допустими за проучванеAll
Приема здрави доброволциДа
Критерии

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

Резултат

Първични изходни мерки

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

Вторични изходни мерки

1. admission or emergency observation [24months]

incidence of admission or emergency observation

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