Frequent Hemodialysis Network - West Coast Consortium

频繁血液透析网络 - 西海岸联盟

• 批准号: 7778708
• 负责人: GLENN MATTHEW CHERTOW
• 金额: $ 5.13万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7778708
• 关键词: Acids; Adherence; Adult; Anemia; Blood Vessels; California; Cardiac; Cardiovascular system; Child; Clinical; Clinical Trials Design; Commit; Communities; Coronary artery; Dialysis procedure; Dietary intake; Disease; Dose; End stage renal failure; Enrollment; Evaluation; Event; Frequencies; Funding; Goals; Hemodialysis; Hemoglobin; Hospitalization; Hospitals; Hypotension; Inflammation; Intake; Kidney; Left; Left Ventricular Mass; Leg; Length of Stay; Maintenance; Medical center; Metabolism; Minerals; Morbidity - disease rate; Movement; Nutritional status; Outcome; Oxidative Stress; Partner in relationship; Personal Satisfaction; Physical Function; Physical activity; Physiologic pulse; Pilot Projects; Principal Investigator; Protein-Energy Malnutrition; Publishing; Pulse Pressure; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research Personnel; Residual state; Restless Legs Syndrome; Risk; SF-36; Safety; Sample Size; Site; Sleep; Stress; Structure; Testing; Thrombosis; Universities; Uremia; Ventricular; Work; attenuation; base; burden of illness; calcification; cognitive function; experience; health related quality of life; hypertension control; improved; industry partner; inflammatory marker; mortality; physical conditioning; primary outcome; programs; racial and ethnic; secondary outcome; socioeconomics; suburb; volume hypertension

DESCRIPTION (provided by applicant): The Frequent Hemodialysis Network (FHN) Study is a randomized clinical trial designed to test hypotheses related to the feasibility, safety, and efficacy of frequent (6x per week) vs. conventional (3x per week) hemodialysis. The recently completed NIDDK-funded MEMO Study demonstrated that survival and many other outcomes were not appreciably influenced by significant increases in equilibrated Kt/Vurea, a parameter of dialysis dose, when hemodialysis was given thrice weekly. Clinical experience and published anecdotal reports suggest that more frequent dialysis may result in reduced frequency and duration of hospitalization, improved control of volume overload, hypertension and anemia, correction of disorders of mineral metabolism, and enhanced quality of life. Given the high mortality rates and significant morbidity associated with end-stage renal disease, a rigorous evaluation of alternative dialysis strategies is warranted. The Investigators have constructed a consortium of University- and community-based nephrologists and dialysis units throughout the state of California - the California Coordinating Clinical Center (CCC). We serve urban and suburban communities with extensive racial, ethnic and socioeconomic diversity. We intend on enrolling 125 subjects (adults and children) as requested by the RFA. Subject recruitment, retention and adherence have been excellent; plans are in place to augment recruitment at existing sites by approaching additional local dialysis facilities and to expand recruitment to VA medical centers affiliated with participating universities. The sample size will not be sufficient to demonstrate a difference in survival among groups. Safety and clinical events (e.g., hospitalization) will continue to be carefully tracked. With continued enrollment and randomization, the study should have sufficient power to detect clinically meaningful differences in the co-primary outcomes (the composite of mortality and change in left ventricular mass; and the composite of mortality and change in the Physical Health Composite of the SF-36). The study should also have sufficient power to detect clinically meaningful differences in other secondary outcomes. Dr. Chertow and his colleages have assembled a talented group of investigators and coordinators. The consortium has worked effectively with multiple industry partners. We are collectively committed to working cooperatively and constructively with the other CCC and DCC to reach all FHN study goals.

描述（由申请人提供）： 频繁血液透析网络（FHN）研究是一项随机临床试验，旨在检验与频繁（每周6次）与常规（每周3次）血液透析的可行性、安全性和有效性相关的假设。最近完成的NIDDK资助的MEMO研究表明，当每周进行三次血液透析时，平衡Kt/Vurea（透析剂量参数）的显著增加不会明显影响生存率和许多其他结局。临床经验和已发表的轶事报告表明，更频繁的透析可能会导致住院频率和住院时间减少，改善容量超负荷、高血压和贫血的控制，纠正矿物质代谢紊乱，提高生活质量。鉴于终末期肾病的高死亡率和显著发病率，有必要对替代透析策略进行严格评价。研究者已经在整个加州州建立了一个由大学和社区肾病学家和透析单位组成的联盟-加州协调临床中心（CCC）。我们服务于具有广泛种族，民族和社会经济多样性的城市和郊区社区。我们计划按照RFA的要求招募125例受试者（成人和儿童）。受试者招募、保留和依从性良好;已制定计划，通过联系其他当地透析机构来增加现有研究中心的招募，并将招募范围扩大到参与大学附属的VA医疗中心。样本量不足以证明组间生存率的差异。安全性和临床事件（例如，住院治疗）将继续仔细跟踪。随着继续入组和随机化，研究应具有足够的把握度来检测共同主要结局（死亡率和左心室质量变化的复合终点;以及死亡率和SF-36身体健康复合终点变化的复合终点）中具有临床意义的差异。该研究还应具有足够的把握度来检测其他次要结局中具有临床意义的差异。Chertow博士和他的同事们组建了一个有才华的调查员和协调员小组。该联盟与多个行业合作伙伴进行了有效合作。我们共同致力于与其他CCC和DCC合作和建设性地工作，以实现所有FHN研究目标。