Chronic Kidney Disease Clinical Trial
Official title:
Reducing Hemodialysis Induced Recurrent Brain Injury to Improve Patients' Lives
NCT number | NCT03342183 |
Other study ID # | 109413 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 8, 2018 |
Est. completion date | October 12, 2022 |
Verified date | October 2022 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | October 12, 2022 |
Est. primary completion date | October 3, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neuro-protection against functionally significant new brain injury | Change from baseline in brain damage as observed by progressive ultrastructural white matter changes on MRI imaging. | 1 year | |
Secondary | Brain Perfusion | Change of brain perfusion from baseline MRI. | 1 year | |
Secondary | Excitotoxic neurotransmitter release | Change in Exitotoxic neurotransmitter release from baseline as seen on the combined MRI. | 1 year | |
Secondary | Microglial Inflammation | Change in microglial Inflammation from baseline as seen on the combined MRI. | 1 year | |
Secondary | Neurological impact | Compare observed brain injury, as determined by MRI, to results on neurocognitive test. | 1 year | |
Secondary | Depression scoring | 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). | 1 year | |
Secondary | Daily activities | Compare observed brain injury, as determined by MRI, to results on evaluation of activities of daily living survey. | 1 year | |
Secondary | Blood work- blood count | 1 year results will be compared to baseline. | 1 year | |
Secondary | Blood work-urea | 1 year results will be compared to baseline. | 1 year | |
Secondary | Blood work-microparticles | 1 year results will be compared to baseline. | 1 year | |
Secondary | Blood work-Cardiac biomarkers (Troponin T, nTproBNP) | 1 year results will be compared to baseline. | 1 year | |
Secondary | Blood work-CRP (C-Reactive Protein) | 1 year results will be compared to baseline. | 1 year | |
Secondary | Blood work-glucose | 1 year results will be compared to baseline. | 1 year | |
Secondary | Blood work- lactate | 1 year results will be compared to baseline. | 1 year | |
Secondary | Blood work- electrolytes | 1 year results will be compared to baseline. | 1 year | |
Secondary | Echocardiogram | Correlated to brain perfusion as well as circulatory stress outputs obtained by the CVInsight devices. | 1 year | |
Secondary | CVInsight | Help us to understand if the CVInsight® Patient Monitoring & Informatics System can be a predictor of organ perfusion | 1 year |
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