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

July 14, 2015 updated by: Yunfeng Xia, First Affiliated Hospital of Chongqing Medical University

The First Affiliated Hospital of Chongqing Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in coronary artery calcification after 1 year's treatment
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Investigators

  • Study Director: Hua Gan, Dr., First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1stChongqingMU snkxia1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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