- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02393222
Assessing Cognitive fUnction and MEasuring the Cerebral circulatioN on HaemoDialysis (ACUMEN-HD)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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.
|
Observing effect of routine HD via transcranial doppler, neurocognitive questionnaires and (in some) brain MRI
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression of white matter hyperintensities on MRI
기간: 12 months
|
Use of visual rating scales to quantify white matter burden at time 0 and 12 months
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Correlation between alterations in cerebral blood flow and cognition
기간: 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
기간: 12 months
|
Statistical correlation between reductions in cerebral bloe
|
12 months
|
Evidence of transient cognitive impairment during HD
기간: 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)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mark D Findlay, MBChB, University of Glasgow
간행물 및 유용한 링크
일반 간행물
- Sozio SM, Armstrong PA, Coresh J, Jaar BG, Fink NE, Plantinga LC, Powe NR, Parekh RS. Cerebrovascular disease incidence, characteristics, and outcomes in patients initiating dialysis: the choices for healthy outcomes in caring for ESRD (CHOICE) study. Am J Kidney Dis. 2009 Sep;54(3):468-77. doi: 10.1053/j.ajkd.2009.01.261. Epub 2009 Apr 19.
- Naganuma T, Takemoto Y, Shoji T, Shima H, Ishimura E, Okamura M, Nakatani T. Factors associated with cerebral white matter hyperintensities in haemodialysis patients. Nephrology (Carlton). 2012 Aug;17(6):561-8. doi: 10.1111/j.1440-1797.2012.01596.x.
- Murray AM, Tupper DE, Knopman DS, Gilbertson DT, Pederson SL, Li S, Smith GE, Hochhalter AK, Collins AJ, Kane RL. Cognitive impairment in hemodialysis patients is common. Neurology. 2006 Jul 25;67(2):216-23. doi: 10.1212/01.wnl.0000225182.15532.40. Erratum In: Neurology. 2007 Jul 3;69(1):120.
- Sarnak MJ, Tighiouart H, Scott TM, Lou KV, Sorensen EP, Giang LM, Drew DA, Shaffi K, Strom JA, Singh AK, Weiner DE. Frequency of and risk factors for poor cognitive performance in hemodialysis patients. Neurology. 2013 Jan 29;80(5):471-80. doi: 10.1212/WNL.0b013e31827f0f7f. Epub 2013 Jan 9.
- Skinner H, Mackaness C, Bedforth N, Mahajan R. Cerebral haemodynamics in patients with chronic renal failure: effects of haemodialysis. Br J Anaesth. 2005 Feb;94(2):203-5. doi: 10.1093/bja/aei016. Epub 2004 Nov 5.
- Murray AM, Seliger S, Lakshminarayan K, Herzog CA, Solid CA. Incidence of stroke before and after dialysis initiation in older patients. J Am Soc Nephrol. 2013 Jun;24(7):1166-73. doi: 10.1681/ASN.2012080841. Epub 2013 Apr 25.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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