Renal Insufficiency, ChronicNCT04929366
Is Hemodialysis Associated With Cardiac Markers Change?
A study testing Hypothermic dialysis followed with routine dialysis and Routine dialysis followed with hypothermic dialysis in people with Renal Insufficiency, Chronic, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Hypothermic dialysis followed with routine dialysis and Routine dialysis followed with hypothermic dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Dec 2017to 16 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with renal insufficiency treated with dialysis for a period of at least three months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hemodialysis With Cooled Dialysate on High Sensitive Cardiac Troponin I (TnI) and Brain Natriuretic Peptide (NT proBNP)
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
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Hypothermic dialysis followed with routine dialysis, Routine dialysis followed with hypothermic dialysis
- Keywords
- End-Stage Kidney Disease, Hypothermic hemodialysis, Cardiovascular events, Troponin T, Brain natriuretic peptide
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic dialysis followed with routine dialysisProcedure or surgery
Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)
Routine dialysis followed with hypothermic dialysisProcedure or surgery
Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)
| Study group | Role | What they receive |
|---|---|---|
| End-stage kidney patients treated in the dialysis unit group 1 | Experimental | Not described Receives: Procedure: Hypothermic dialysis followed with routine dialysis |
| End-stage kidney patients treated in the dialysis unit group 2 | Experimental | Not described Receives: Procedure: Routine dialysis followed with hypothermic dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start18 Dec 2017
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osamah Hussein, Ziv Hospital
- Investigators
- Younes Bathish, MD, Principal investigator, Ziv Medical Centre, Safed, Israel / Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929366
- Sponsor's protocol ID
- 0101-17-ZIV
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hemodialysis With Cooled Dialysate on High Sensitive Cardiac Troponin I (TnI) and Brain Natriuretic Peptide (NT proBNP)
- ClinicalTrials.gov ID
- NCT04929366
- Acronym / sponsor ID
- 0101-17-ZIV
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- End-Stage Kidney Disease, Hypothermic hemodialysis, Cardiovascular events, Troponin T, Brain natriuretic peptide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-stage kidney patients treated in the dialysis unit group 1 | Experimental | Procedure: Hypothermic dialysis followed with routine dialysis |
| End-stage kidney patients treated in the dialysis unit group 2 | Experimental | Procedure: Routine dialysis followed with hypothermic dialysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with renal insufficiency treated with dialysis for a period of at least three months.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermic dialysis followed with routine dialysisHypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate) | Procedure or surgery | End-stage kidney patients treated in the dialysis unit group 1 |
| Routine dialysis followed with hypothermic dialysisRoutine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate) | Procedure or surgery | End-stage kidney patients treated in the dialysis unit group 2 |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Younes Bathish, MD principal investigator
Ziv Medical Centre, Safed, Israel / Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermic dialysis followed with routine dialysis and Routine dialysis followed with hypothermic dialysis in people with Renal Insufficiency, Chronic, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.