MedDataX Logo

The Effects of Different Dialysate Calcium Concentration

NCT ID: NCT01839383

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mineral-bone Metabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DCa1.25

using dialysate calcium concentration 1.25 mmol/L(DCa1.25)

Group Type ACTIVE_COMPARATOR

different dialysate calcium concentration

Intervention Type OTHER

DCa1.5

using dialysate calcium concentration 1.5mmol/L

Group Type ACTIVE_COMPARATOR

different dialysate calcium concentration

Intervention Type OTHER

DCa1.75

using dialysate calcium concentration 1.75mmol/L

Group Type ACTIVE_COMPARATOR

different dialysate calcium concentration

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

different dialysate calcium concentration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wenhu Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Friendship hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wenhu Liu, Doctor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BJFH-EC/2013-020

Identifier Type: -

Identifier Source: org_study_id