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

Chongqing Medical University

Status: Unknown

Conditions: Coronary Artery Calcification

Treatments: Other: low calcium dialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02498457

1stChongqingMU snkxia1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

low calcium dialysis

Active Comparator group

Description:

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

Treatment:

Other: low calcium dialysis

Routine dialysis

Other group

Description:

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

Treatment:

Other: low calcium dialysis