Is Hemodialysis Associated With Cardiac Markers Change?

Ziv Hospital45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Renal Insufficiency, Chronic

Interventions

Hypothermic dialysis followed with routine dialysisPROCEDURE

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

Routine dialysis followed with hypothermic dialysisPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nephrology Department, Ziv Medical Center

Safed, Israel

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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