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Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration

Primary Purpose

Myocardial Stunning, End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Change the dialysate calcium concentration
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Stunning focused on measuring myocardial stunning, dialysate calcium concentration, nutritional status, hemodinamic, hemodialysis

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients on conventional hemodialysis

Exclusion Criteria:

  • Congestive heart failure, arrhythmia, active infection, cancer

Sites / Locations

  • Hospital das Clinicas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Calcium dialysate 2.5mEq/L

Calcium dialysate 3.5mEq/L

Arm Description

Dialysis with low calcium concentration

Dialysis with high calcium concentration

Outcomes

Primary Outcome Measures

myocardial stunning diagnosis by echocardiography technique strain
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

Secondary Outcome Measures

Full Information

First Posted
August 17, 2014
Last Updated
March 12, 2019
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02545426
Brief Title
Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration
Official Title
Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Stunning, End-stage Renal Disease
Keywords
myocardial stunning, dialysate calcium concentration, nutritional status, hemodinamic, hemodialysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium dialysate 2.5mEq/L
Arm Type
Active Comparator
Arm Description
Dialysis with low calcium concentration
Arm Title
Calcium dialysate 3.5mEq/L
Arm Type
Active Comparator
Arm Description
Dialysis with high calcium concentration
Intervention Type
Other
Intervention Name(s)
Change the dialysate calcium concentration
Intervention Description
The dialysate calcium concentration will be changed according to the prior concentration
Primary Outcome Measure Information:
Title
myocardial stunning diagnosis by echocardiography technique strain
Description
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
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients on conventional hemodialysis Exclusion Criteria: Congestive heart failure, arrhythmia, active infection, cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosilene M Elias, M.D., Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

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Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration

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