Is Hemodialysis Associated With Cardiac Markers Change?

Study Overview
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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

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

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Procedure: Hypothermic dialysis followed with routine dialysis
* Procedure: Routine dialysis followed with hypothermic dialysis


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br> | Procedure: Hypothermic dialysis followed with routine dialysis<br>* Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)<br>|
| Experimental: End-stage kidney patients treated in the dialysis unit group 2<br> | Procedure: Routine dialysis followed with hypothermic dialysis<br>* Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Stage Kidney Disease, Hypothermic hemodialysis, Cardiovascular events, Troponin T, Brain natriuretic peptide