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

Study Overview
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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.

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.

Official Title
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The First Affiliated Hospital of Chongqing Medical University

Conditions
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Coronary Artery Calcification

Intervention / Treatment
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* Other: low calcium dialysis


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low calcium dialysis<br>patients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L. | Other: low calcium dialysis<br>* patients in this group will receive low calcium dialysis for 1 year.<br>|
| Other: Routine dialysis<br>Patients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L. | Other: low calcium dialysis<br>* patients in this group will receive low calcium dialysis for 1 year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in coronary artery calcification after 1 year's treatment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maintenance hemodialysis patients, coronary artery calcification, low calcium dialysate, effects, safety