Reducing Hemodialysis Induced Recurrent Brain Injury to Improve Patients' Lives

NCT03342183 | Completed

• 1 other identifier: 109413
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Dialysis; Hemodialysis; Remote Ischemic Preconditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Brain Perfusion

  1 year

• Excitotoxic neurotransmitter release

  1 year

• Microglial Inflammation

  1 year

• Neurological impact

  1 year

• Depression scoring

  1 year

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

SHAM COMPARATOR

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

Interventions

Intervention Arm OTHER

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).

Intervention Arm

Control Arm OTHER

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Anazodo UC, Wong DY, Theberge J, Dacey M, Gomes J, Penny JD, van Ginkel M, Poirier SE, McIntyre CW. Hemodialysis-Related Acute Brain Injury Demonstrated by Application of Intradialytic Magnetic Resonance Imaging and Spectroscopy. J Am Soc Nephrol. 2023 Jun 1;34(6):1090-1104. doi: 10.1681/ASN.0000000000000105. Epub 2023 Mar 9.

  PMID: 36890644 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher McIntyre, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Kidney Clinical Research Unit

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 14, 2017
• Study Start: January 8, 2018
• Primary Completion: October 3, 2022
• Study Completion: October 12, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

CA (1)