NCT02545426

Myocardial Stunning During Hemodialysis: Role of Dialyste Calcium Concentration

Completed NA Last updated 12 March 2019

What this trial tests

NA trial testing Change the dialysate calcium concentration in Myocardial Stunning in 19 participants. Completed in 1 April 2016.

Timeline

1 July 2015

Primary endpoint
1 April 2016

1 April 2016

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	19
Start date	1 July 2015
Primary completion	1 April 2016
Estimated completion	1 April 2016
Sites	1 location across Brazil

Drugs / interventions tested

• Change the dialysate calcium concentration

Conditions studied

• Myocardial Stunning — all drugs for Myocardial Stunning →
• End-stage Renal Disease — all drugs for End-stage Renal Disease →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 17 to 70, any sex, with Myocardial Stunning or End-stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. High Dialysate Calcium Concentration is Associated with Worsening Left Ventricular Function.
   Silva VB, Macedo TA, Braga TMS, Silva BC, et al · · 2019 · cited 1× · PMID 30787343 · DOI 10.1038/s41598-019-38887-y