- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545426
Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration
March 12, 2019 updated by: Rosilene Motta Elias Coelho, University of Sao Paulo General Hospital
Chronic kidney disease (CKD) is linked to elevated mortality rate, and cardiovascular disease is the main cause related to this outcome.
The cardiovascular mortality among patients on conventional hemodialysis (CHD) is high, achieving up to 30 times more risk of death when comparing to individuals of same age on general population.
Congestive heart failure can develop in 25% to 50% of patients, leading to a worse prognosis.
CKD patients present anatomic and functional abnormalities on peripheral bed vases and also cardiovascular abnormalities that can cause myocardial ischemia.
This last usually is transitory and lead to left ventricular dysfunction that can persist even after the end of dialysis session despite normal coronary perfusion.
The prolonged dysfunction is called myocardial stunning (MS).
Patients on CHD are subject to hemodynamic instability, myocardial ischemia and development of regional abnormalities of myocardial wall (ARPM´s).
MS induced by intradialytic ischemia is a complication that can be minimized by applying techniques associated to more stability during the CHD, as cool dialysate or increasing the length of the therapy.
The goal of the present study is to evaluate the behavior of cardiovascular system (trough hemodynamic performance during CHD, accessing MS by echocardiography technique, and biomarkers associated to MS).
Finally, the investigators aimed to investigate the role of two different dialysate calcium concentration (2,5 and 3,5 mEq/l) in the genesis of MS during CHD.
The elucidation of pathogenesis of MS during CHD might help us modified hemodialysis technique in order to prevent MS, and reduce the high cardiovascular mortality among CKD patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients on hemodialysis patients present anatomic and functional abnormalities on peripheral bed vases and also cardiovascular abnormalities that can cause myocardial ischemia.
This last usually is transitory and lead to left ventricular dysfunction that can persist even after the end of dialysis session despite normal coronary perfusion.
The prolonged dysfunction is called myocardial stunning (MS).
Patients on dialysis are subject to hemodynamic instability, myocardial ischemia and development of regional abnormalities of myocardial wall (ARPM´s).
Some authors have demonstrated that CHD cause segmental and global myocardial ischemia, and up to 65% of patients have recurrent myocardial ischemia.
There are some associated factors: high ultrafiltration rates, intradialytic hypotension, reduced systolic blood pressure and high risk of cardiovascular events and death.
MS induced by intradialytic ischemia is a complication that can be minimized by applying techniques associated to more stability during the CHD, as cool dialysate or increasing the length of the therapy.
More specifically, MS can be the result of repair process, with oxygen free radicals generation and reduction of the synthesis of contractile proteins, in association with a reduced muscle responses to calcium which in turns lead to ventricular dysfunction (the calcium hypothesis).
The goal of the present study is to evaluate the behavior of cardiovascular system (trough hemodynamic performance during CHD, accessing MS by echocardiography technique, and biomarkers associated to MS).
Finally, the investigators aimed to investigate the role of two different dialysate calcium concentration (2,5 and 3,5 mEq/l) in the genesis of MS during CHD.
The elucidation of pathogenesis of MS during CHD might help us modified hemodialysis technique in order to prevent MS, and reduce the high cardiovascular mortality among CKD patients.
Study Type
Interventional
Enrollment (Actual)
19
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
-
-
SP
-
Sao Paulo, SP, Brazil, 05403-000
- Hospital das Clínicas
-
-
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
17 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients on conventional hemodialysis
Exclusion Criteria:
- Congestive heart failure, arrhythmia, active infection, cancer
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Calcium dialysate 2.5mEq/L
Dialysis with low calcium concentration
|
The dialysate calcium concentration will be changed according to the prior concentration
|
Active Comparator: Calcium dialysate 3.5mEq/L
Dialysis with high calcium concentration
|
The dialysate calcium concentration will be changed according to the prior concentration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
myocardial stunning diagnosis by echocardiography technique strain
Time Frame: 1 week
|
Investigate the role of two different dialysate calcium concentration (2,5 and 3,5 mEq/l) in the genesis of myocardial stunning diagnosis by echocardiography technique strain
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rosilene M Elias, M.D., Ph.D., University of Sao Paulo
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
July 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
August 17, 2014
First Submitted That Met QC Criteria
September 9, 2015
First Posted (Estimate)
September 10, 2015
Study Record Updates
Last Update Posted (Actual)
March 14, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Myocardial stunning - Calcium
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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