Shroff Rukshana, Bayazit Aysun, Stefanidis Constantinos J, Askiti Varvara, Azukaitis Karolis, Canpolat Nur, Agbas Ayse, Anarat Ali, Aoun Bilal, Bakkaloglu Sevcan, Bhowruth Devina, Borzych-Dużałka Dagmara, Bulut Ipek Kaplan, Büscher Rainer, Dempster Claire, Duzova Ali, Habbig Sandra, Hayes Wesley, Hegde Shivram, Krid Saoussen, Licht Christoph, Litwin Mieczyslaw, Mayes Mark, Mir Sevgi, Nemec Rose, Obrycki Lukasz, Paglialonga Fabio, Picca Stefano, Ranchin Bruno, Samaille Charlotte, Shenoy Mohan, Sinha Manish, Smith Colette, Spasojevic Brankica, Vidal Enrico, Vondrák Karel, Yilmaz Alev, Zaloszyc Ariane, Fischbach Michel, Schaefer Franz, Schmitt Claus Peter
Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, UK.
Cukurova University, Adana, Turkey.
BMC Nephrol. 2018 Aug 10;19(1):199. doi: 10.1186/s12882-018-0998-y.
Cardiovascular disease is prevalent in children on dialysis and accounts for almost 30% of all deaths. Randomised trials in adults suggest that haemodiafiltration (HDF) with high convection volumes is associated with reduced cardiovascular mortality compared to high-flux haemodialysis (HD); however paediatric data are scarce. We designed the haemodiafiltration, heart and height (3H) study to test the hypothesis that children on HDF have an improved cardiovascular risk profile, growth and nutritional status and quality of life, compared to those on conventional HD. We performed a non-randomised parallel-arm intervention study within the International Paediatric Haemodialysis Network Registry comparing children on HDF and conventional HD to determine annualised change in cardiovascular end-points and growth. Here we present the 3H study design and baseline characteristics of the study population.
190 children were screened and 177 (106 on HD and 71 on HDF) recruited from 28 centres in 10 countries. There was no difference in age, underlying diagnosis, comorbidities, previous dialysis therapy, dialysis vintage, residual renal function, type of vascular access or blood flow between HD and HDF groups. High flux dialysers were used in 63% of HD patients and ultra-pure water was available in 52%. HDF patients achieved a median convection volume of 13.3 L/m; this was associated with the blood flow rate only ((p = 0.0004, r = 0.42) and independent of access type (p = 0.38).
This is the largest study on dialysis outcomes in children that involves deep phenotyping across a wide range of cardiovascular, anthropometric, nutritional and health-related quality of life measures, to test the hypothesis that HDF leads to improved cardiovascular and growth outcomes compared to conventional HD.
ClinicalTrials.gov: NCT02063776 . The trial was prospectively registered on the 14 Feb 2014.
心血管疾病在接受透析的儿童中很常见,占所有死亡人数的近30%。成人随机试验表明,与高通量血液透析(HD)相比,高对流容量的血液透析滤过(HDF)与心血管死亡率降低有关;然而儿科数据很少。我们设计了血液透析滤过、心脏与身高(3H)研究,以检验与接受传统HD的儿童相比,接受HDF的儿童心血管风险状况、生长及营养状况和生活质量得到改善这一假设。我们在国际儿科血液透析网络注册中心内进行了一项非随机平行组干预研究,比较接受HDF和传统HD的儿童,以确定心血管终点和生长的年化变化。在此我们介绍3H研究设计及研究人群的基线特征。
从10个国家的28个中心筛选了190名儿童,招募了177名(106名接受HD,71名接受HDF)。HD组和HDF组在年龄、潜在诊断、合并症、既往透析治疗、透析龄、残余肾功能、血管通路类型或血流量方面无差异。63%的HD患者使用高通量透析器,52%可获得超纯水。HDF患者的对流容量中位数为13.3L/m;这仅与血流速率相关((p = 0.0004, r = 0.42)),且与通路类型无关(p = 0.38)。
这是关于儿童透析结局的最大规模研究,涉及对广泛的心血管、人体测量、营养和健康相关生活质量指标进行深度表型分析,以检验与传统HD相比,HDF能改善心血管和生长结局这一假设。
ClinicalTrials.gov:NCT02063776 。该试验于2014年2月14日进行前瞻性注册。