Is Hemodialysis Associated With Cardiac Markers Change?

NCT ID: NCT04929366

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2020-11-16

Brief Summary

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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

Detailed Description

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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End-stage kidney patients treated in the dialysis unit group 1

Group Type EXPERIMENTAL

Hypothermic dialysis followed with routine dialysis

Intervention Type PROCEDURE

Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)

End-stage kidney patients treated in the dialysis unit group 2

Group Type EXPERIMENTAL

Routine dialysis followed with hypothermic dialysis

Intervention Type PROCEDURE

Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)

Interventions

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Hypothermic dialysis followed with routine dialysis

Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)

Intervention Type PROCEDURE

Routine dialysis followed with hypothermic dialysis

Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Osamah Hussein

Head of Internal Medicine A

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Younes Bathish, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Centre, Safed, Israel / Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel

Locations

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Nephrology Department, Ziv Medical Center

Safed, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0101-17-ZIV

Identifier Type: -

Identifier Source: org_study_id

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