Back to resultsThe Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients
Primary Purpose
Coronary Artery Calcification
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low calcium dialysis
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Calcification focused on measuring maintenance hemodialysis patients, coronary artery calcification, low calcium dialysate, effects, safety
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
low calcium dialysis
Routine dialysis
Arm Description
patients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L.
Patients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L.
Outcomes
Primary Outcome Measures
Changes in coronary artery calcification after 1 year's treatment
Secondary Outcome Measures
The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study
Full Information
NCT ID
NCT02498457
First Posted
July 13, 2015
Last Updated
July 14, 2015
Sponsor
First Affiliated Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02498457
Brief Title
The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients
Official Title
The First Affiliated Hospital of Chongqing Medical University
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Calcification
Keywords
maintenance hemodialysis patients, coronary artery calcification, low calcium dialysate, effects, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low calcium dialysis
Arm Type
Active Comparator
Arm Description
patients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L.
Arm Title
Routine dialysis
Arm Type
Other
Arm Description
Patients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L.
Intervention Type
Other
Intervention Name(s)
low calcium dialysis
Intervention Description
patients in this group will receive low calcium dialysis for 1 year.
Primary Outcome Measure Information:
Title
Changes in coronary artery calcification after 1 year's treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunfeng Xia, Dr.
Phone
86-23-89012256
Email
xyf0920@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Gan, Dr.
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Hao, MD
Phone
86-23-89012409
Email
ghzxgckd@163.com
12. IPD Sharing Statement
Learn more about this trial
The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients
We'll reach out to this number within 24 hrs