Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02545426
Collaborator
(none)
19
1
2
9
2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Change the dialysate calcium concentration
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Calcium dialysate 2.5mEq/L

Dialysis with low calcium concentration

Other: Change the dialysate 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

Other: Change the dialysate calcium concentration
The dialysate calcium concentration will be changed according to the prior concentration

Outcome Measures

Primary Outcome Measures

  1. myocardial stunning diagnosis by echocardiography technique strain [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients on conventional hemodialysis
Exclusion Criteria:
  • Congestive heart failure, arrhythmia, active infection, cancer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital das Clinicas Sao Paulo SP Brazil 05403-000

Sponsors and Collaborators

  • University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Rosilene M Elias, M.D., Ph.D., University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rosilene Motta Elias Coelho, M.D., Ph.D., University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02545426
Other Study ID Numbers:
  • Myocardial stunning - Calcium
First Posted:
Sep 10, 2015
Last Update Posted:
Mar 14, 2019
Last Verified:
Mar 1, 2019
Keywords provided by Rosilene Motta Elias Coelho, M.D., Ph.D., University of Sao Paulo General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2019