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

The First Affiliated Hospital of Chongqing Medical University

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02498457
Enrollment
200
Registered
2015-07-15
Start date
2014-09-30
Completion date
2016-03-31
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Calcification

Keywords

maintenance hemodialysis patients, coronary artery calcification, low calcium dialysate, effects, safety

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.

Interventions

OTHERlow calcium dialysis

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

Sponsors

First Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Changes in coronary artery calcification after 1 year's treatment1 year

Secondary

MeasureTime frame
The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study1 year

Countries

China

Contacts

Primary ContactYunfeng Xia, Dr.
xyf0920@126.com86-23-89012256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026