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Completed

NCT Number: NCT04929366

Is Hemodialysis Associated With Cardiac Markers Change?

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

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology Department, Ziv Medical Center

Safed, 13100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypothermic dialysis followed with routine dialysis

Procedure

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

Routine dialysis followed with hypothermic dialysis

Procedure

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

Primary outcomes

  1. Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability

    Time frame: 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).

  2. Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ziv Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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