Is Hemodialysis Associated With Cardiac Markers Change?

June 9, 2021 updated by: Osamah Hussein, Ziv Hospital

Effects of Hemodialysis With Cooled Dialysate on High Sensitive Cardiac Troponin I (TnI) and Brain Natriuretic Peptide (NT proBNP)

Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

  • Israel
      • Safed, Israel, 13100
        • Nephrology Department, Ziv Medical Center

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with renal insufficiency treated with dialysis for a period of at least three months.

Exclusion Criteria:

  • Patients who experienced myocardial infarction during the three months prior to the start of the study
  • Patients who underwent vascular surgery during the last month
  • Patients who experienced chest pain at rest during the last week before the start of the trial - Patients who had to discontinue dialysis prematurely due to hemodynamic instability.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: End-stage kidney patients treated in the dialysis unit group 1
Procedure: Hypothermic dialysis followed with routine dialysis
Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)
Experimental: End-stage kidney patients treated in the dialysis unit group 2
Procedure: Routine dialysis followed with hypothermic dialysis
Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability
Time Frame: one year
For each patient, four blood pressure measurements including systolic blood pressure, diastolic blood pressure and mean arterial pressure were performed at the beginning, after 2 hours, after 3 hours after 4 hours (end of hemodialysis).
one year
Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis
Time Frame: 6 months
Blood samples were collected at the beginning of the dialysis session, and a second sample was taken in the last 5 minutes of hemodialysis in order to evaluate the relationship between hemodialysis with cooled dialysate (hypothermic dialysis) and the myocardial markers hs-TnI and NTproBNP and to monitor hypothermic hemodiaysis treatment response.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Investigators

  • Principal Investigator: Younes Bathish, MD, Ziv Medical Centre, Safed, Israel / Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel

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 (Actual)

December 18, 2017

Primary Completion (Actual)

November 16, 2020

Study Completion (Actual)

November 16, 2020

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0101-17-ZIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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