Post-Discharge Nephrology Follow-up for Improved Outcomes

出院后肾脏病学随访以改善结果

• 批准号: 10296363
• 负责人: Chirag R Parikh
• 金额: $ 66.67万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-19 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10296363
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Adult; Algorithms; Angiotensin Receptor; Angiotensin-Converting Enzyme Inhibitors; Biological Markers; Biological Process; Blood; Blood Pressure; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Chronic Kidney Failure; Clinic; Clinical; Clinical Investigator; Complication; Consent; Counseling; Creatinine; Development; Disease Progression; Effectiveness; Electronic Health Record; Eligibility Determination; Enrollment; Evaluation; Event; Fibrosis; Funding; Glomerular Filtration Rate; Goals; Health; Hospital Mortality; Hospitalization; Hospitals; Incidence; Inflammation; Intervention; Kidney; Kidney Diseases; Link; Measurement; Medical; Medical Research; Mission; Modification; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Outcome; Patient Care; Patient Outcomes Assessments; Patient Recruitments; Patients; Perioperative; Persons; Pharmaceutical Preparations; Phenotype; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Recovery; Recurrence; Renal function; Research; Research Personnel; Risk; Risk Factors; Serum; Site; Survivors; Syndrome; System; Techniques; Telemedicine; Time; Translational Research; Trauma; Urine; Visit; Work; adverse outcome; blood pressure regulation; cardiovascular health; cardiovascular risk factor; clinical care; comorbidity; diabetes control; efficacy evaluation; evidence base; experience; follow-up; health assessment; hospital readmission; improved; improved outcome; inhibitor/antagonist; injury and repair; innovation; insight; interdisciplinary approach; medication safety; mortality; mortality risk; nephrotoxicity; pilot trial; precision medicine; primary outcome; prognostic; randomized trial; recruit; research clinical testing; research study; satisfaction; screening; standard of care; translational scientist; treatment as usual; trend; trial comparing

PROJECT SUMMARY/ABSTRACT Acute kidney injury (AKI) is a common complication experienced by roughly 20% of adult patients during hospitalization. AKI is associated with long-term adverse outcomes including cardiovascular disease and death, as well as chronic kidney disease (CKD). Although serum creatinine may improve or normalize after an episode of AKI, the biological processes of injury, repair, and fibrosis may continue for months afterwards; thus during this time period, interventions can be implemented to improve long-term outcomes. Indeed, early post- discharge follow-up with a nephrologist after severe AKI has been associated with a 25% reduction in mortality in pilot trials. The overall objective of this multicenter clinical trial is to definitively evaluate the impact of systematic post-discharge nephrology follow-up among patients with in-hospital AKI in a dedicated transitional care clinic after acute kidney injury (TCC-AKI) and compare it with the standard of care. The rationale is that the first few months after hospital discharge represent a critical window of time in which medical interventions may have a significant impact on long-term kidney outcomes. This intervention will consist of telemedicine or in-person visits in which nephrologists will address several key domains of patient care that can influence long- term clinical outcomes, including blood pressure management, medication reconciliation, cardiovascular health assessment, and patient counseling. We will emphasize appropriate care management targets for several comorbid risk factors. The overarching hypothesis is that timely longitudinal follow-up at the TCC-AKI post- discharge in patients with KDIGO Stages 2 and 3 AKI will result in improved intermediate and long-term clinical outcomes compared to usual care, with better patient-reported outcomes as well. The overall objective will be achieved by pursuing 3 specific aims: 1) to recruit patients with KDIGO stages 2 and 3 AKI during hospitalization to a randomized clinical trial of post-discharge AKI follow-up; 2) to ascertain intermediate outcomes in patients receiving post-discharge AKI follow-up compared to those receiving usual care; and 3) to ascertain long-term outcomes of post-discharge AKI follow-up compared to those receiving usual care. Under Aim 1, patients will be recruited into this study for randomization to systematic AKI follow-up in a TCC-AKI. Under Aim 2, intermediate outcomes, including recurrent AKI and hospitalizations will be evaluated. Under Aim 3, long-term outcomes including CKD incidence, CKD progression, and mortality will be assessed. The research proposed here is innovative for its multidisciplinary approach, use of cutting-edge techniques, integration of telemedicine for clinical use, and development of a systematic approach to post-discharge AKI follow-up. This work will be significant because rigorously conducted randomized studies and translational research studies are needed to evaluate the efficacy of post-discharge AKI follow-up for widespread clinical use and will advance ambulatory nephrology care by providing insights into the effectiveness of systematic post-discharge AKI follow-up.

项目总结/摘要 急性肾损伤（阿基）是一种常见的并发症，大约有20%的成年患者在治疗过程中经历过。 住院阿基与长期不良结局相关，包括心血管疾病和 死亡，以及慢性肾病（CKD）。虽然血清肌酐可能会改善或正常化后， 阿基发作后，损伤、修复和纤维化的生物学过程可能会持续数月;因此， 在此期间，可以实施干预措施以改善长期结果。其实，早在 重度阿基后由肾病专家进行出院随访，死亡率降低25% 在试点试验中。这项多中心临床试验的总体目标是明确评估 在一个专门的过渡期，对住院阿基患者进行系统的出院后肾脏病学随访 急性肾损伤（TCC-AKI）后的护理诊所，并将其与标准护理进行比较。基本原理是 出院后的头几个月是一个关键的时间窗口， 可能会对长期肾脏预后产生重大影响。这种干预将包括远程医疗或 在面对面的访问中，肾病学家将解决患者护理的几个关键领域，这些领域可能影响长期的 长期临床结局，包括血压管理、药物协调、心血管健康 评估和患者咨询。我们将强调适当的护理管理目标， 共病危险因素。总体假设是TCC-AKI后及时的纵向随访， KDIGO 2期和3期阿基患者的出院将改善中期和长期临床 与常规护理相比，患者报告的结局也更好。总体目标是 通过追求3个具体目标实现：1）招募KDIGO 2期和3期阿基患者， 出院后阿基随访的随机临床试验; 2）确定中间 与接受常规治疗的患者相比，接受出院后阿基随访的患者的结局;以及3） 确定出院后阿基随访与接受常规护理的患者相比的长期结局。下 目的1，本研究将招募患者，随机分配至TCC-AKI的系统性阿基随访。 在目标2下，将评价中间结局，包括复发性阿基和住院治疗。目标之下 3、将评估长期结局，包括CKD发生率、CKD进展和死亡率。的 这里提出的研究是创新的多学科方法，使用尖端技术， 整合远程医疗用于临床，并开发出院后阿基的系统方法 随访这项工作将是重要的，因为严格进行的随机研究和翻译 需要研究来评估出院后阿基随访的有效性， 使用并将通过提供对系统性治疗有效性的见解来推进非卧床肾脏病治疗。 出院后阿基随访。