Is Hemodialysis Associated With Cardiac Markers Change?

Not Applicable

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Procedure: Hypothermic dialysis followed with routine dialysis; Procedure: Routine dialysis followed with hypothermic dialysis

• Registration Number: NCT04929366
• Lead Sponsor: Ziv Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-12-18
• Primary Completion: 2020-11-16
• Study Completion: 2020-11-16
• Status Verified: 2021-06
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
End-stage kidney patients treated in the dialysis unit group 1	Hypothermic dialysis followed with routine dialysis	-
End-stage kidney patients treated in the dialysis unit group 2	Routine dialysis followed with hypothermic dialysis	-

Primary Outcome Measures

Name	Time	Method
Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability	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).
Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis	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.

Trial Locations

Locations (1)

Nephrology Department, Ziv Medical Center; 🇮🇱 Safed, Israel