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

Not Applicable

• Conditions: Coronary Artery Calcification
• Interventions: Other: low calcium dialysis

• Registration Number: NCT02498457
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-07
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low calcium dialysis	low calcium dialysis	patients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L.
Routine dialysis	low calcium dialysis	Patients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L.

Primary Outcome Measures

Name	Time	Method
Changes in coronary artery calcification after 1 year's treatment	1 year

Secondary Outcome Measures

Name	Time	Method
The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study	1 year

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China