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

March 18, 2015 updated by: NHS Greater Glasgow and Clyde

Exploring the Natural History of Cerebrovascular Disease in Patients With End-stage Renal Disease on Haemodialysis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients receiving haemodialysis for end-stage renal disease.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 4 hour treatment period (of HD)
Correlation between alterations in cerebral blood flow and white matter hyperintensity burden progression
Time Frame: 12 months
Statistical correlation between reductions in cerebral bloe
12 months
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.
Within 2 weeks (direct comparison of cognition during dialysis and on non-dialysis day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Mark D Findlay, MBChB, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN14RE639

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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