NCT02545426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

August 17, 2014

Last Update Submit

March 12, 2019

Conditions

Myocardial StunningEnd-stage Renal Disease

Keywords

myocardial stunningdialysate calcium concentrationnutritional statushemodinamichemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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

    1 week

Study Arms (2)

Calcium dialysate 2.5mEq/L

ACTIVE COMPARATOR

Dialysis with low calcium concentration

Other: Change the dialysate calcium concentration

Calcium dialysate 3.5mEq/L

ACTIVE COMPARATOR

Dialysis with high calcium concentration

Other: Change the dialysate calcium concentration

Interventions

Change the dialysate calcium concentrationOTHER

The dialysate calcium concentration will be changed according to the prior concentration

Calcium dialysate 2.5mEq/LCalcium dialysate 3.5mEq/L

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients on conventional hemodialysis

You may not qualify if:

  • Congestive heart failure, arrhythmia, active infection, cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Myocardial StunningKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Rosilene M Elias, M.D., Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

August 17, 2014

First Posted

September 10, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

BR(1)