Exploring the Natural History of Cerebrovascular Disease in Patients With End-stage Renal Disease on Haemodialysis
试验速览
- 阶段
- 不适用
- 入组人数
- 97
- 主要终点
- Progression of white matter hyperintensities on MRI
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients treated with HD at the Glasgow Renal Unit and its satellite units
排除标准
- •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)
结局指标
主要结局
Progression of white matter hyperintensities on MRI
时间窗: 12 months
Use of visual rating scales to quantify white matter burden at time 0 and 12 months
次要结局
- Correlation between alterations in cerebral blood flow and cognition(Within 4 hour treatment period (of HD))
- Correlation between alterations in cerebral blood flow and white matter hyperintensity burden progression(12 months)
- Evidence of transient cognitive impairment during HD(Within 2 weeks (direct comparison of cognition during dialysis and on non-dialysis day))