Analysis of associations between anemia correction in CKD and mortality: CHOIR

CKD 贫血纠正与死亡率之间的关联分析：CHOIR

• 批准号: 7903343
• 负责人: Huiman X Barnhart
• 金额: $ 15.14万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-29 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7903343
• 关键词: Ache; Activities of Daily Living; Anemia; Anxiety; Cardiovascular Diseases; Cessation of life; Characteristics; Chronic Kidney Failure; Clinical; Clinical Research; Communities; Complex; Data; Data Coordinating Center; Data Set; Demographic Factors; Dialysis procedure; Dizziness; Dose; Eating Behavior; End stage renal failure; Epoetin Alfa; Event; Exercise; Future; Goals; Happiness; Health; Health Status; Hematocrit procedure; Hemoglobin; Hemoglobin concentration result; Hospitalization; Intervention; Iron; Kidney Failure; Leg Cramp; Life; Logic; Measures; Morbidity - disease rate; Muscle Weakness; Outcome; Patients; Performance; Physicians; Population; Quality of life; Research; Research Institute; Research Personnel; Resistance; Risk; Shortness of Breath; Sleep; Societies; Subgroup; Supplementation; Well in self; Work; cardiovascular risk factor; clinically relevant; improved; interest; mortality; public health relevance; randomized trial; response; satisfaction; sex; treatment strategy; trend

DESCRIPTION (provided by applicant): Summary of Work Anemia is common among patients with chronic kidney disease (CKD) and is associated with increased mortality, increased rates of cardiovascular disease and hospitalization, and decreased quality of life. Treatment of anemia with epoetin-alfa in CKD patients improves most quality of life parameters including energy and activity level, functional ability, sleep and eating behavior, health status, satisfaction with health, sex life, well- being, psychological effect, life satisfaction, and happiness, exercise capacity, energy, and strength with a significant reduction in aching dizziness, anxiety, shortness of breath, muscle weakness, and leg cramps. Counterintuitive to these findings, the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) Trials demonstrated a trend or a statistically significant increase in the risk of cardiovascular events or death. Given that prior observational work demonstrated an increased risk of death associated with higher doses of epoetin alfa, these findings are particularly interesting. This application is offered by investigators at the Duke Clinical Research Institute which served as the data coordinating center for the CHOIR Trial and has the right to use its' retained copy of the CHOIR dataset for its own research. This application outlines the secondary analyses to be performed utilizing the CHOIR dataset to provide the clinical community with a greater depth of understanding as to the factors associated anemia correction that may have contributed most to the increased risk caused by targeting a higher hemoglobin. PUBLIC HEALTH RELEVANCE: Since the introduction of epoetin alfa, its use in the chronic kidney disease and dialysis populations has been popular and endorsed by thought leaders and professional societies due to its demonstrated effects on hemoglobin levels and quality of life. Because anemia correction has been associated with beneficial effects for many outcomes such as quality of life and higher hemoglobin is associated with improved survival, anemia correction became a national clinical performance measure. Given the counterintuitive findings of the CHOIR trial that greater anemia correction causes an increase in the risk of cardiovascular morbidity and mortality, this application will examine the complex associations between anemia correction and outcomes to generate hypotheses that will guide the need for future research and assist the clinician in choosing target, dose, and treatment strategy.

描述（由申请人提供）：贫血概述在慢性肾脏疾病（CKD）患者中很常见，并且与死亡率增加，心血管疾病和住院率的增加以及生活质量降低有关。在CKD患者中用依epoetin-alfa治疗贫血可改善大多数生活质量参数，包括能量和活动水平，功能能力，睡眠和饮食行为，健康状况，对健康，性生活，良好，福祉，心理上的满意​​，心理上的满意​​，生活满意度，幸福感，运动能力，锻炼能力，能量和力量以及对疼痛，焦虑，焦虑，焦虑，呼吸衰弱的大量降低以及效果的大幅度降低，以及nosce弱的弱点，并cr脚不断变化。与这些发现的违反直觉，矫正血红蛋白和肾功能不全（合唱团）试验的结果表明，心血管事件或死亡的风险趋势或统计学上显着增加。鉴于先前的观察工作表明，与较高剂量的Epoetin alfa相关的死亡风险增加，因此这些发现特别有趣。该申请是由杜克临床研究所的调查人员提供的，该研究所作为合唱团试验中心的数据协调中心，并有权使用其保留的合唱团数据集副本进行自己的研究。该应用程序概述了使用合唱团数据集对临床社区的二级分析进行的二级分析，以使对相关的贫血矫正因素具有更深入的理解，这些因素可能对靶向更高的血红蛋白造成的风险最大。 公共卫生相关性：自从引入Epoetin alfa以来，由于其对血红蛋白水平和生活质量的影响，其在慢性肾脏疾病和透析人群中的使用受到了思想领袖和专业社会的流行和认可。由于贫血的校正与许多结果（例如生活质量和更高的血红蛋白）的有益作用有关，与提高的生存率有关，因此贫血矫正成为了国家的临床表现措施。鉴于合唱团试验的违反直觉发现，更大的贫血校正会导致心血管发病率和死亡率的风险增加，因此该应用将研究贫血校正和结果之间的复杂关联，以产生假设，以引起对未来研究的需求，并帮助临床医生选择目标，DOSE和治疗策略。