Back to resultsIs Hemodialysis Associated With Cardiac Markers Change?
Primary Purpose
Renal Insufficiency, Chronic
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hypothermic dialysis followed with routine dialysis
Routine dialysis followed with hypothermic dialysis
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring End-Stage Kidney Disease, Hypothermic hemodialysis, Cardiovascular events, Troponin T, Brain natriuretic peptide
Eligibility Criteria
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.
Sites / Locations
- Nephrology Department, Ziv Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
End-stage kidney patients treated in the dialysis unit group 1
End-stage kidney patients treated in the dialysis unit group 2
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04929366
Brief Title
Is Hemodialysis Associated With Cardiac Markers Change?
Official Title
Effects of Hemodialysis With Cooled Dialysate on High Sensitive Cardiac Troponin I (TnI) and Brain Natriuretic Peptide (NT proBNP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
November 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziv Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
End-Stage Kidney Disease, Hypothermic hemodialysis, Cardiovascular events, Troponin T, Brain natriuretic peptide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
End-stage kidney patients treated in the dialysis unit group 1
Arm Type
Experimental
Arm Title
End-stage kidney patients treated in the dialysis unit group 2
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hypothermic dialysis followed with routine dialysis
Intervention Description
Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)
Intervention Type
Procedure
Intervention Name(s)
Routine dialysis followed with hypothermic dialysis
Intervention Description
Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)
Primary Outcome Measure Information:
Title
Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability
Description
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
Title
Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Younes Bathish, MD
Organizational Affiliation
Ziv Medical Centre, Safed, Israel / Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Department, Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
12. IPD Sharing Statement
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Is Hemodialysis Associated With Cardiac Markers Change?
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