The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.

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Detailed Description

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MHD patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/L) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/L). All patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. They were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. All patients received heart spiral CT examination before and at the end of the study. Coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.

Conditions

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Coronary Artery Calcification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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low calcium dialysis

patients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L.

Group Type ACTIVE_COMPARATOR

low calcium dialysis

Intervention Type OTHER

patients in this group will receive low calcium dialysis for 1 year.

Routine dialysis

Patients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L.

Group Type OTHER

low calcium dialysis

Intervention Type OTHER

patients in this group will receive low calcium dialysis for 1 year.

Interventions

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low calcium dialysis

patients in this group will receive low calcium dialysis for 1 year.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH \<500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.
* Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.
* Patients who signed informed consent documents at the time of enrollment in the study.

Exclusion Criteria

* Patients whose heart or lung function are poor, or with unstable hemodynamics.
* Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.
* Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes