Feasibility of obtaining measured glomerular filtration rate among young adults with cerebral palsy

获得脑瘫青壮年肾小球滤过率测定值的可行性

• 批准号: 10463784
• 负责人: Daniel Whitney
• 金额: $ 7.8万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-06 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10463784
• 关键词: Address; Adopted; Adult; Age; Age-Years; Aging; Agreement; Body fat; Cardiovascular system; Cerebral Palsy; Cessation of life; Child; Childhood; Chronic Kidney Failure; Classification; Clinic; Clinical; Clinical Protocols; Clinical assessments; Complex; Consent; Creatinine; Development; Disease; Disease Progression; Early Intervention; Enrollment; Equation; Etiology; Exercise; Fatty acid glycerol esters; Foundations; Future; Glomerular Filtration Rate; Goals; Gold; Health; Healthcare; Incidence; Individual; Intervention; Interview; Iothalamate; Kidney; Kidney Diseases; Knowledge; Lead; Longevity; Measurement; Measures; Methods; Mission; Monitor; Morbidity - disease rate; Motor; Muscle; National Institute of Child Health and Human Development; Outcome; Participant; Patients; Pentetic Acid; Personal Satisfaction; Population; Predisposition; Premature Birth; Procedures; Protocols documentation; Public Health; Race; Renal function; Research; Risk; Serum; Severities; System; Technical Expertise; Testing; Treatment Efficacy; Vulnerable Populations; Work; acceptability and feasibility; blood pressure control; burden of illness; clinical practice; cost; disability; epidemiology study; experience; improved; innovation; kidney dysfunction; method development; mortality; motor disorder; multidisciplinary; multiple chronic conditions; novel; post gamma-globulins; premature; prevent; recruit; research clinical testing; research study; societal costs; standard measure; therapy development; young adult; young man; young woman

PROJECT SUMMARY Young adults 18-40 years of age with cerebral palsy (CP) have unmet healthcare needs and heightened susceptibility for kidney disease, which may result in greater risk for premature morbidity and mortality; however, little is known about kidney function for individuals with CP. This is due to misinterpretation of clinical measures of kidney function that are not appropriate for CP, leading to inaccurate assessment of kidney function. Interventions at earlier stages of kidney dysfunction can be highly effective at mitigating long-term risk of kidney disease; however, intervention efforts are hindered without accurate assessments of glomerular filtration rate (GFR), the clinical gold-standard measure of kidney function, in patients with CP. No studies have measured GFR (mGFR) for CP. The feasibility of obtaining mGFR in adults with CP is unknown, as is the accuracy of estimating GFR (eGFR) using traditional equations through non-invasive methods. There may be specific barriers in mGFR testing for adults with CP. Therefore, identifying clinical feasibility and reasonable accommodations to accurately assess mGFR is a vital first step. The long-term goal is to understand, prevent, and treat kidney dysfunction to improve healthful aging for individuals with CP. The objective of this study is to lay the foundation for future research and clinical intervention by determining the clinical feasibility of obtaining mGFR using the widely adopted clinical test, 125I-Iothalamate, and the 99mTc-DTPA test, which is a less- involved clinical protocol, for young adults 18-40 years old with CP. Specifically, the primary Aim of this study will measure the proportion of those consented to those approached, proportion of those completing testing procedures to those consented, acceptability of testing using validated measures, and exit interviews that probe barriers and facilitators to enrollment and testing challenges for both the participants with CP and the experienced technicians obtaining mGFR. The exit interviews will allow us to identify and develop reasonable accommodations to enhance recruitment and completion of testing for future research studies and to inform clinical practice. If both clinical protocols prove reliable mGFR measures as determined by routine clinical standards, we will explore: (1) the agreement between tests, which will provide evidence of which test can be used for research and clinic; and (2) the degree of discrepancy between mGFR and eGFR by severity of CP. This information will initiate needed work in providing a clinically-friendly CP correction factor or a CP-specific equation for eGFR to improve clinical monitoring of kidney function for this vulnerable population. The research is innovative because it will challenge the current status quo that kidney function is normal for CP, which is due to misinterpretation of kidney function from routinely used clinical measures that are not appropriate for CP rather than true kidney function. The research is significant because accurate assessment of kidney function for CP is necessary for clinical interventions to prevent the onset and delay the progression of kidney disease.

项目摘要 18-40岁的年轻人患有脑性麻痹（CP）有未满足的医疗保健需求，并增加了 肾脏疾病的敏感性，这可能会导致更大的发病率和死亡率的风险更大； 但是，对于CP个体的肾功能知之甚少。这是由于误解了临床 不适合CP的肾功能的度量，导致肾脏评估不准确 功能。肾功能障碍早期阶段的干预措施可以非常有效地减轻长期风险 肾脏疾病；但是，在没有准确评估肾小球的情况下阻碍干预工作 CP患者的过滤率（GFR），肾功能的临床金标准量度。没有研究 用于CP的GFR（MGFR）。在患有CP的成年人中获得MGFR的可行性尚不清楚， 通过非侵入性方法使用传统方程估算GFR（EGFR）的精度。可能有 CP成人MGFR测试中的特定障碍。因此，确定临床可行性和合理 准确评估MGFR的住宿是至关重要的第一步。长期目标是理解，预防， 并治疗肾脏功能障碍，以改善CP患者的健康衰老。这项研究的目的是 通过确定获得的临床可行性，为未来的研究和临床干预奠定基础 MGFR使用广泛采用的临床测试，125i-iothalamate和99MTC-DTPA测试，这是一个较少的 涉及临床方案，适用于18-40岁患有CP的年轻人。具体而言，这项研究的主要目的 将衡量同意与接近的人的比例，那些完成测试的人的比例 同意的程序，使用经过验证的措施的测试可接受性，并退出访谈 探究障碍和促进者，为CP和CP参与者的注册和测试挑战 经验丰富的技术人员获得了MGFR。退出访谈将使我们能够识别并发展合理 为了增强招聘和完成未来研究的测试的住宿，并告知 临床实践。如果两种临床方案都证明了可靠的MGFR测量，则通过常规临床确定 标准，我们将探讨：（1）测试之间的协议，这将提供哪种测试的证据 用于研究和诊所； （2）MGFR和EGFR之间通过CP的严重程度的差异。 该信息将启动所需的工作，以提供临床友好的CP校正因子或CP特定的工作 EGFR的方程式以改善该脆弱人群的肾脏功能的临床监测。研究 具有创新性，因为它会挑战当前的现状，即CP肾功能是正常的，这将是由于 从常规使用的临床指标中误解了肾脏功能，而不适用于CP 而不是真正的肾功能。这项研究很重要，因为对肾功能的准确评估 对于CP来说，对于防止肾脏疾病的发作和延迟进展，必须采取临床干预措施。