Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany; German Center for Mental Health (DZPG), Berlin, Germany.
Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany; German Center for Mental Health (DZPG), Berlin, Germany.
Kidney Int. 2024 Nov;106(5):961-971. doi: 10.1016/j.kint.2024.07.014. Epub 2024 Jul 30.
In the CONVINCE trial, the primary analysis demonstrated a survival benefit for patients receiving high-dose hemodiafiltration (HDF) as compared with high-flux hemodialysis (HD). A secondary objective was to evaluate effects on health-related quality of life (HRQoL); assessed in eight domains (physical function, cognitive function, fatigue, sleep disturbance, anxiety, depression, pain interference, social participation) applying instruments from the Patient-Reported Outcome Measurement Information System (PROMIS) before randomization and every three months thereafter. In total 1360 adults with dialysis-dependent chronic kidney disease, eligible to receive high-flux HDF (23 liters or more), were randomized (1:1); 84% response rate to all questionnaires. Both groups reported a continuous deterioration in all HRQoL domains. Overall, raw score changes from baseline were more favorable in the HDF group, resulting in a significant omnibus test after a median observation period of 30 months. Most relevant single raw score differences were reported for cognitive function. Patients receiving HDF reported a decline of -0.95 units (95% confidence interval - 2.23 to +0.34) whereas HD treated patients declined by -3.90 units (-5.28 to - 2.52). A joint model, adjusted for mortality differences, utilizing all quarterly assessments, identified a significantly slower HRQoL decline in physical function, cognitive function, pain interference, and social participation for the HDF group. Their physical health summary score declined -0.46 units/year slower compared to the HD group. Thus, the CONVINCE trial showed a beneficial effect of high-dose hemodiafiltration for survival as well as a moderate positive effect on patients' quality of life, most pronounced with respect to their cognitive function. REGISTRATION: NTR7138 on the International Clinical Trials Registry Platform.
在 CONVINCE 试验中,主要分析表明,与高通量血液透析(HD)相比,接受高剂量血液透析滤过(HDF)的患者有生存获益。次要目标是评估对健康相关生活质量(HRQoL)的影响;使用来自患者报告结局测量信息系统(PROMIS)的工具在随机分组前和此后每三个月评估 8 个领域(身体功能、认知功能、疲劳、睡眠障碍、焦虑、抑郁、疼痛干扰、社会参与)。共有 1360 名接受透析治疗的慢性肾脏病患者有资格接受高通量 HDF(23 升或以上),随机分组(1:1);对所有问卷的应答率为 84%。两组患者在所有 HRQoL 领域均报告持续恶化。总体而言,HDF 组的原始评分变化更为有利,在中位观察期 30 个月后进行了综合检验。最相关的单个原始评分差异报告发生在认知功能领域。接受 HDF 治疗的患者报告下降了 -0.95 个单位(95%置信区间 -2.23 至 0.34),而 HD 治疗的患者下降了 -3.90 个单位(-5.28 至 -2.52)。利用所有季度评估结果,调整死亡率差异的联合模型确定 HDF 组在身体功能、认知功能、疼痛干扰和社会参与方面的 HRQoL 下降速度明显较慢。与 HD 组相比,他们的身体健康综合评分每年下降速度慢 0.46 个单位。因此,CONVINCE 试验表明高剂量血液透析滤过不仅对生存有有益影响,而且对患者的生活质量有适度的积极影响,在认知功能方面最为明显。注册:在国际临床试验注册平台上注册为 NTR7138。