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Reducing Hemodialysis Induced Recurrent Brain Injury to Improve Patients' Lives

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ClinicalTrials.gov Identifier: NCT03342183
Recruitment Status : Unknown
Verified February 2019 by Chris McIntyre, Lawson Health Research Institute.
Recruitment status was:  Recruiting
First Posted : November 14, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Chris McIntyre, Lawson Health Research Institute

Brief Summary:
Patients who receive dialysis for kidney failure suffer severe cognitive impairment. Hemodialysis causes circulatory stress and ischemia, which causes severe brain injury. It has been demonstrated that a procedure known as Remote Ischemic Preconditioning(RIPC), which involves wrapping a blood pressure cuff around a patient's leg and inflating has the potential of protecting many organs, such as the heart from the effects of dialysis. Our study aims to investigate this phenomenon to determine the extent to which it provides protection to a dialysis patient's brain.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Intervention Arm Other: Control Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Hemodialysis Induced Recurrent Brain Injury to Improve Patients' Lives
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Intervention Arm
RIPC stimulus will be applied prior to the first intervention visit, using a previously validated (for cardiac protection in HD patients) standard dose (four cycles of cuff inflation to the lower limb of the patient and inflating at 200mmHg for five minutes, with five minutes' deflation). To be administered on a monthly basis from the baseline visit to the year 1 visit.
Other: Intervention Arm
RIPC stimulus will be applied prior to the first intervention visit, using a previously validated (for cardiac protection in HD patients) standard dose (four cycles of cuff inflation to the lower limb of the patient and inflating at 200mmHg for five minutes, with five minutes' deflation).

Sham Comparator: Control Arm
Sham procedure in which the blood pressure cuff will be applied to the lower limb and inflated to 40mmHg for five minutes and deflated for five minutes with the cycle repeated a total of four times prior to dialysis. To be administered on a monthly basis from the baseline visit to the year 1 visit.
Other: Control Arm
Sham procedure in which the blood pressure cuff will be applied to the lower limb and inflated to 40mmHg for five minutes and deflated for five minutes with the cycle repeated a total of four times prior to dialysis. To be administered on a monthly basis from the baseline visit to the year 1 visit.




Primary Outcome Measures :
  1. Neuro-protection against functionally significant new brain injury [ Time Frame: 1 year ]
    Change from baseline in brain damage as observed by progressive ultrastructural white matter changes on MRI imaging.


Secondary Outcome Measures :
  1. Brain Perfusion [ Time Frame: 1 year ]
    Change of brain perfusion from baseline MRI.

  2. Excitotoxic neurotransmitter release [ Time Frame: 1 year ]
    Change in Exitotoxic neurotransmitter release from baseline as seen on the combined MRI.

  3. Microglial Inflammation [ Time Frame: 1 year ]
    Change in microglial Inflammation from baseline as seen on the combined MRI.

  4. Neurological impact [ Time Frame: 1 year ]
    Compare observed brain injury, as determined by MRI, to results on neurocognitive test.

  5. Depression scoring [ Time Frame: 1 year ]
    Compare observed brain injury, as determined by MRI, to results on depression scoring test.We will be utilizing the PHQ-9(Patient Health Questionnaire) which is used for screening, diagnosing, monitoring, and measuring the severity of depression. This test consists of 9 questions regarding symptoms which factor into the scoring severity index. Each question is given a score from 0-3, which represents responses such as: not at all(0), several days(1), more than half the days (2), and nearly everyday(3). The scores can be interpreted as follows: 5-9 (minimal symptoms), 10-14 (Minor depression, mild), 15-19 (major depression, moderately severe), and >20 (major depression, severe).

  6. Daily activities [ Time Frame: 1 year ]
    Compare observed brain injury, as determined by MRI, to results on evaluation of activities of daily living survey.

  7. Blood work- blood count [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  8. Blood work-urea [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  9. Blood work-microparticles [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  10. Blood work-Cardiac biomarkers (Troponin T, nTproBNP) [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  11. Blood work-CRP (C-Reactive Protein) [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  12. Blood work-glucose [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  13. Blood work- lactate [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  14. Blood work- electrolytes [ Time Frame: 1 year ]
    1 year results will be compared to baseline.

  15. Echocardiogram [ Time Frame: 1 year ]
    Correlated to brain perfusion as well as circulatory stress outputs obtained by the CVInsight devices.

  16. CVInsight [ Time Frame: 1 year ]
    Help us to understand if the CVInsight® Patient Monitoring & Informatics System can be a predictor of organ perfusion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female
  • Having hemodialysis treatment at least three times per week
  • Must be 18 years old or older.
  • Ability to speak and understand English

Exclusion Criteria:

  • Exposure to hemodialysis for less than 90 days prior to recruitment
  • Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) of less than 18 or with a formal diagnosis of dementia)
  • Previous clinical stroke
  • Taking drugs to blunt response to RIPC (e.g. ciclosporin, ATP-sensitive potassium channel directed drugs)
  • Dialysing using lower limb vascular access
  • Pregnancy, breastfeeding, or intending pregnancy
  • Unable to give consent or understand written information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342183


Contacts
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Contact: Christopher McIntyre 519-661-2111 ext 56557 christopher.mcintyre@lhsc.on.ca
Contact: Janice Gomes jgomes32@uwo.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Chris McIntyre, MD    519-685-8500 ext 58502    christopher.mcintyre@lhsc.on.ca   
Contact: Jarrin Penny    519-685-8500 ext 58765    jarrin.penny@lhsc.on.ca   
Principal Investigator: Christopher W McIntyre, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Christopher McIntyre, MD London Health Sciences Centre
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Responsible Party: Chris McIntyre, Director of Kidney Clinical Research Unit, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03342183    
Other Study ID Numbers: 109413
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris McIntyre, Lawson Health Research Institute:
Dialysis
Hemodialysis
Remote Ischemic Preconditioning
Additional relevant MeSH terms:
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Brain Injuries
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries