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

Coronary Artery Calcification Clinical Trial

Official title:

The First Affiliated Hospital of Chongqing Medical University

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02498457
• Other study ID #: 1stChongqingMU snkxia1
• Status: Unknown status
• Phase: N/A
• First received: July 13, 2015
• Last updated: July 14, 2015
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Yunfeng Xia, Dr.
• Phone: 86-23-89012256
• Email: xyf0920[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Calcification
• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in coronary artery calcification after 1 year's treatment		1 year
Secondary	The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study		1 year