NL-OMON47563已完成不适用
Impact on Neurocognitive Performance in Children, Adolescents and Young Adults of Chronic Kidney Disease and its Therapy: A Feasibility Study. - The INPACT: a feasibility study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •Inclusioncriteria for patients with CKD:
- •* Patients with CKD 4-5/ESRD or ESRD patients who underwent renal transplantation at least one years ago.
- •* aged 8-30 years.
- •* Sufficient visual and hearing acuity
- •* Dutch language fluency
- •* Willingness to give informed consent;Inclusioncriteria for three patients with familial uremia:
- •* Diagnosis of familial uremia.
- •* age 12 to 50 years
- •* Sufficient visual and hearing acuity
- •* Dutch language fluency
- •* Willingness to give informed consent;Healthy controls must meet all of the following criteria
- •* Sibling of the candidate, healthy classmate or close friend of the CKD patient.
- •* No diagnosis of CKD, or other chronic disease with primary or secondary CNS involvement
- •* Informed consent obtained from the participant or legal guardian if the participant is below 18 years
- •* age 8-30 year
- •* Sufficient visual and hearing acuity
- •* Dutch language fluency
- •* Willingness to give informed consent
排除标准
- •For both patients and healthy controls:
- •* Pre-existing documented cognitive impairment
- •* Active, uncontrolled psychiatric illness
- •* Substance abuse
- •* A history of cerebrovascular disease (either transitory ischaemic attack or cerebrovascular accident)
- •* Brain injury
- •* Epilepsy
- •* Diabetes mellitus
- •* Patients will be excluded from MRI scanning in case of MR contraindications, including implanted active devices or objects (e.g. cardiac pacemaker, implantable defibrillator, medication pump, intracranial aneurysm clips, cochlear implant and other implants), metal splinters near sensitive organs (e.g. eye, brain or lungs) or claustrophobia. They are eligible to participate in the other measurements of the study protocol.
- •* Any condition that can be expected to interfere with complete follow-up
- •* Patients participating in group 1 of the ALLEGRO trial (adult patients)
- •* HLA-identical family transplantations
研究者
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