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Assessing Cognitive fUnction and MEasuring the Cerebral circulatioN on HaemoDialysis (ACUMEN-HD)

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ClinicalTrials.gov Identifier: NCT02393222
Recruitment Status : Unknown
Verified March 2015 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2015
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:

Stroke disease and cognitive impairment are common in patients established on haemodialysis (HD) for end-stage renal disease (ESRD). Further, initiation of HD appears to transiently increase the risk of stroke. The mechanism by which this occurs is not known.

Using ultrasound, patient questionnaires and brain MRI our study will observe changes in cognition and cerebral blood flow whilst receiving HD compared to a non-dialysis day. Transient clinical and ultrasound alterations will be correlated to radiographic changes in cerebral perfusion and structure on MRI to determine the underlying mechanism for the increased stroke risk. The investigators will observe this effect in the immediate and longer term (12 months observation).

A greater understanding will allow development of effective preventive strategies.


Condition or disease Intervention/treatment
End-Stage Renal Disease Stroke Cognition Disorders Other: Observing effect of routine HD

Detailed Description:

Stroke is common in the United Kingdom and a leading cause of adult disability. It has been reported that more than half of all stroke survivors remain dependent on carers for everyday activities. A greater understanding stroke disease has led to improvements in stroke care for the general population.

Patients with ESRD are at increased risk of cerebrovascular disease with a risk approximately 5-10 times higher than the general population yet a relative paucity of data exploring the mechanisms and impact of stroke disease on patients on HD remains. Signs of cerebrovascular disease are common with evidence of early stroke disease (white matter hyperintensities on MRI) having been described in up to 50% of ESRD patients. In addition to this it is now estimated that up to 70% of patients on dialysis aged 55 years and older have moderate to severe cognitive impairment. Previous work has revealed that cognition declines during dialysis - specifically a decrease in executive function has been reported, without significant memory impairment. Such findings are in suggestive of vascular related injury. Mean cerebral blood flow assessed by transcranial Doppler ultrasound is reduced during dialysis, although whether this finding is associated with a clinical outcome is not clear.

In order to generate appropriate preventive strategies for stroke in ESRD the mechanism by which injury occurs must be confirmed. In addition, although a decrease in executive function has been shown during HD it is unclear if long-term HD is associated with progressive decline or if this clinical finding correlates with neuroimaging.

This study is being performed to determine:

  • The impact of long term HD (including indices of cardiovascular instability) on changes on brain MRI and cognitive function.
  • The relationship between intracerebral blood flow rate, brain MRI findings and neurocognitive function
  • The relationship between intracranial blood flow measures (during and post haemodialysis (HD)) and brain perfusion and structure

Following informed written consent patients will be observed over a 12 month period. On the first visit participants will undergo a transcranial ultrasound before and during HD to achieve baseline and intra-dialytic blood flow velocities. During the dialysis sessions a neurocognitive assessment (patient questionnaire) will be performed which will assess multiple cognitive domains. On completion of dialysis a subgroup will undergo a brain MRI. All patients will meet with the investigators within 2 weeks to repeat the neurocognitive assessment on a non-dialysis day. This will allow for comparison of cognitive changes, alterations in cerebral blood flow and (in some) correlation with MRI findings. All participants will repeat this process 12 months later.


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Study Type : Observational
Estimated Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring the Natural History of Cerebrovascular Disease in Patients With End-stage Renal Disease on Haemodialysis
Study Start Date : March 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with ESRD on HD
Adult patients with ESRD on HD. Observing the effect of a single HD session on cerebral blood flow (assessed by transcranial doppler) and cognitive function (assessed by neurocognitive questionnaires). Subgroup to undergo brain MRI.
Other: Observing effect of routine HD
Observing effect of routine HD via transcranial doppler, neurocognitive questionnaires and (in some) brain MRI




Primary Outcome Measures :
  1. Progression of white matter hyperintensities on MRI [ Time Frame: 12 months ]
    Use of visual rating scales to quantify white matter burden at time 0 and 12 months


Secondary Outcome Measures :
  1. Correlation between alterations in cerebral blood flow and cognition [ Time Frame: Within 4 hour treatment period (of HD) ]
    Statistical correlation determined between a decreased in cerebral blood flow (as measured on transcranial doppler) and reduction in cognitive scores on assessment

  2. Correlation between alterations in cerebral blood flow and white matter hyperintensity burden progression [ Time Frame: 12 months ]
    Statistical correlation between reductions in cerebral bloe

  3. Evidence of transient cognitive impairment during HD [ Time Frame: Within 2 weeks (direct comparison of cognition during dialysis and on non-dialysis day) ]
    Use of multi-domain neurocognitive battery to assess cognition during HD. Baseline cognition will be assessed on a non-dialysis day.


Biospecimen Retention:   Samples With DNA
Samples will be taken with consent for serum biomarkers. Consent will be sought for DNA testing in the future, following favourable ethical review


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients receiving haemodialysis for end-stage renal disease.
Criteria

Inclusion Criteria:

  • Adult patients treated with HD at the Glasgow Renal Unit and its satellite units

Exclusion Criteria:

  • Planned live donor transplant is planned during the next 6 months
  • Predicted life expectancy <6 months
  • Inability to give informed consent
  • Contraindications to MRI imaging (pacemaker, extreme claustrophobia),
  • Known clinical or radiological diagnoses of cerebrovascular disease
  • Severe cognitive impairment (MOCA <17)

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): NCT02393222


Contacts
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Contact: Mark D Findlay, MBChB 01413304739 mark.findlay@glasgow.ac.uk
Contact: Patrick B Mark, MBChB PhD 0141 3308218 patrick.mark@glasgow.ac.uk

Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
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Principal Investigator: Mark D Findlay, MBChB University of Glasgow

Publications:

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02393222     History of Changes
Other Study ID Numbers: GN14RE639
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by NHS Greater Glasgow and Clyde:
Dialysis
Cerebrovascular disease
ESRD
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Cognition Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Neurocognitive Disorders
Mental Disorders