Atlanta Sickle Cell Disease Clinical Research Consortium

亚特兰大镰状细胞病临床研究联盟

• 批准号: 7393088
• 负责人: Peter Anthony Lane
• 金额: $ 31.96万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-17 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7393088
• 关键词: Adolescent; Adult; Adverse effects; Analgesics; Angiotensin II; Angiotensin Receptor; Area; Award; Caring; Child; Childhood; Chronic Kidney Failure; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Conduct Clinical Trials; Data; Data Quality; Discipline of Nursing; Doctor of Philosophy; Dose; Double-Blind Method; Elements; Enrollment; Environment; Funding; Health; Health system; Healthcare; Histamine Release; Infusion procedures; Kidney Diseases; Losartan; Microalbuminuria; Morbidity - disease rate; Morphine; Multi-Institutional Clinical Trial; Nalbuphine; Numbers; Outcome; Pain; Patients; Performance; Persons; Phase; Placebos; Population; Prevention strategy; Principal Investigator; Purpose; Randomized; Randomized Controlled Clinical Trials; Rate; Recruitment Activity; Research Infrastructure; Research Personnel; Safety; Sickle Cell; Sickle Cell Anemia; Structure; Testing; Therapy Clinical Trials; Universities; Upper arm; Work; acute chest syndrome; design; experience; improved; macroalbuminuria; medical schools; mortality; professor; prospective; respiratory; sickling; success

The purpose of the RFA for a Sickle Cell Disease (SCO) Clinical Research Network (CRN) is to establish an infrastructure with 15 clinical centers that will design and perform multi-center therapeutic trials to improve health outcomes in persons with sickle cell disease. Clinical investigators from the Emory and Morehouse Schools of Medicine propose to establish one of the 15 clinical centers in Atlanta. The proposal includes three elements: The Clinical Research Core will contribute to the design and implementation of SCO CRN studies, and enroll subjects at Children's Healthcare of Atlanta and the Grady Health System. Project 1 will test the hypothesis that losartan, an angiotensin receptor antagonist, will reduce the rate of progression of renal disease in patients with sickle nephropathy. The hypothesis will be tested in two groups: patients with macroalbuminuria and overt nephropathy, and patients with microalbuminuria. In addition to determining the effect on progressive renal disease, the study will compare the safety and tolerability of losartan vs. placebo when administered long-term in albuminuric patients with sickle cell nephropathy. Project 2 is a prospective phase III randomized trial to test the hypothesis that nalbuphine is superior to morphine in the treatment of vaso-occlusive pain in SCO because patients will suffer fewer episodes of acute chest syndrome and will suffer fewer side effects because of less respiratory suppression and reduced release of histamine. A second hypothesis is that high-dose PCA with low-dose infusion of analgesic is superior to low-dose PCA with high-dose infusion. The hypothesis will be tested by a four-arm study that will compare morphine to nalbuphine and low-dose constinuous infusion with high-dose PCA to high-dose infusion with low-dose PCA for each analgesic. The work of the CRN will contribute importantly to lessening morbidity and mortality from complications of SCO. Two two proposed projects will improve treatment of pain, the most common and disabling manifestation of SCO and lessen the impact of chronic kidney disease.

镰状细胞病（SCO）临床研究网络（CRN）RFA的目的是建立一个 基础设施与15个临床中心，将设计和执行多中心治疗试验，以改善 镰状细胞病患者的健康结果。埃默里和莫尔豪斯的临床研究者 医学院建议在亚特兰大建立15个临床中心之一。这项提议包括 三个要素： 临床研究核心将有助于SCO CRN研究的设计和实施， 亚特兰大儿童保健和格雷迪卫生系统的受试者。 项目1将检验一种血管紧张素受体拮抗剂氯沙坦将降低 镰状肾病患者的肾脏疾病进展。假设将在两个 组：大量白蛋白尿和显性肾病患者，以及微量白蛋白尿患者。在 除了确定对进行性肾病的影响外，该研究还将比较 氯沙坦与安慰剂在镰状细胞白蛋白尿患者中长期给药的耐受性 肾病 项目2是一项前瞻性III期随机试验，旨在检验纳布啡上级于 吗啡在治疗SCO的血管闭塞性疼痛，因为患者将遭受更少的急性发作 胸部综合征，并会遭受较少的副作用，因为较少的呼吸抑制和减少 释放组胺。第二个假设是，高剂量PCA与低剂量镇痛剂输注， 上级优于低剂量PCA和高剂量输注。这一假设将通过一项四臂研究进行检验， 比较吗啡与纳布啡和低剂量持续输注与高剂量PCA与高剂量PCA 每种镇痛剂均输注低剂量PCA。 CRN的工作将为减少并发症的发病率和死亡率做出重要贡献。 上合组织两个两个拟议的项目将改善治疗疼痛，最常见的和禁用 慢性肾脏病的治疗方法有哪些？