Is Hemodialysis Associated With Cardiac Markers Change?

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929366
• Other study ID #: 0101-17-ZIV
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: November 16, 2020

Study information

• Verified date: June 2021
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Hypothermic dialysis followed with routine dialysis
Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)
• Routine dialysis followed with hypothermic dialysis
Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)

Locations

Country	Name	City	State
Israel	Nephrology Department, Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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