A Longitudinal Assessment of Cognitive Impairment in Advanced CKD Transitioning Into Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To test the feasibility of performing serial detailed neurocognitive assessments in patients before during and after the period of commencing RRT for End-Stage Kidney Disease
研究概览
简要总结
Patients with failed kidneys need Renal Replacement Therapy (RRT) to remove fluid and toxins from the body. The 3 types of RRT are kidney transplant or removal of waste by dialysis, either via the blood (haemodialysis) or via the stomach area (peritoneal dialysis). 27,000 patients currently receive dialysis in the UK and some endure reduced quality-of-life, depression, and thinking and memory difficulties. Some of these symptoms reflect undiagnosed dementia. Indeed up to 7/10 dialysis patients suffer moderate to severe brain impairment or dementia - much more frequently than in the general population.
This study will assess brain function just before starting dialysis/transplant and at 3 and 12 months afterwards with face to face assessments and with brain scans in some patients. Changes in brain function will be compared between people treated with the different forms of dialysis and transplant.
The Investigators hope to evaluate whether these tests are acceptable to patients, whether affected sub-groups with cognitive impairment can be identified early, and if certain dialysis methods are better for patients with cognitive impairment/dementia, so that a larger study to try to improve brain function after RRT can be developed.
详细描述
Aims of the proposed research
Primary Objective:
To test the feasibility of performing serial detailed neurocognitive assessments in patients before during and after the period of commencing RRT for End-Stage Kidney Disease
Secondary Objectives:
- Estimate cross-sectional and longitudinal variability in a novel battery of neurocognitive assessments amongst participants in transition to all 3 modalities of RRT.
- Assess the administration, suitability and adherence of the chosen cognitive and quality of life measures in participants.
- Test the feasibility of recruitment to a longitudinal brain magnetic resonance imaging (MRI) study in a randomly selected proportion of participants.
- Estimate the cross-sectional and longitudinal variability in multiparametric brain MRI parameters and their interaction with cognitive functional change in this transitional population.
- To describe resource implications including patients referred to specialist services due to new diagnoses of cognitive impairment, dementia and/or depression
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eGFR <15/ml/min/1.73m2
- •Aged 55 years and over
- •Mental capacity to understand the study and give informed consent
排除标准
- •Age <55 years
- •Non-English speaking
- •Patients known to have a psychiatric condition, including severe depression, bipolar affective disorder, severe anxiety, panic disorder, substance misuse or psychosis or previous severe head injury
- •Contraindications to magnetic resonance imaging
- •Patients who have chosen not to undergo dialysis treatment (conservative care).
结局指标
主要结局
To test the feasibility of performing serial detailed neurocognitive assessments in patients before during and after the period of commencing RRT for End-Stage Kidney Disease
时间窗: 2.5years
Number of patients eligible, no of patients consented, number of patients who underwent both baseline and longitudinal neurocognitive assessments
次要结局
- Test the feasibility of recruitment to a longitudinal brain magnetic resonance imaging (MRI) study in a randomly selected proportion of participants.(18 months)
- Estimate cross-sectional and longitudinal variability in a novel battery of neurocognitive assessments amongst participants in transition to all 3 modalities of RRT.(2.5years)
- Estimate the cross-sectional and longitudinal variability in multiparametric brain MRI parameters and their interaction with cognitive functional change in this transitional population.(2.5years)
- Assess the administration, suitability and adherence of the chosen cognitive and quality of life measures in participants.(2.5 years)
- To describe resource implications including patients referred to specialist services due to new diagnoses of cognitive impairment, dementia and/or depression(2,5 years)
研究者
Natalie Garratt
Research Development Lead
Northern Care Alliance NHS Foundation Trust