A Pilot stuDy to Investigate the Role of Biomarkers and Bioimpedance technologY to Assess VolumE Status In Patients underGoing Hemodialysis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Correlation of sCD146 level with overhydration assessed by bioimpedance technology
研究概览
简要总结
A precise volume status assessment is critical to improve outcome of patients on dialysis. Yet, accurate assessment of fluid status remains a challenge. Currently, this is performed by clinical evaluation and regular weight measurements before and after dialysis, which is not always accurate. Moreover, bioimpedance technology is used in some centers for quantitative assessment of total body water. This approach has been validated for the assessment of volume status in dialysis patients, but requires the acquisition of specific tools and is time consuming. So far, no biomarker has been validated to quantify volume status in dialysis patients. Application of biomarkers might contribute to a better dialysis prescription and therefore to outcome improvement in dialysis. The investigators aim to investigate the role of a novel biomarkers (sCD146) to assess volume status in dialysis patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Patient on dialysis since > 1 month
- •Voluntarily signed informed consent
排除标准
- •Pregnant or breastfeeding women and women who plan to get pregnant during study
- •Incapability of following the study protocol
- •Acute illness
- •Hospitalizations in the last week before inclusion
- •Cardiac pacemakers or defibrillators
- •Limb amputation or other factors precluding a reliable bioimpedance measurement (unreliable bioimpedance measurement)
结局指标
主要结局
Correlation of sCD146 level with overhydration assessed by bioimpedance technology
时间窗: 3 weeks to 3 months
For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months
次要结局
- Correlation of sCD146 level and clinical evaluation of volume status(3 weeks to 3 months)
- Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up(6 months)
- Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up(6 months)
- Correlation of sCD146 level measured after dialysis and ultrafiltration rate(3 weeks)
- Correlation of sCD146 level and level of NT-proBNP(3 weeks to 3 months)
- Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up(6 months)
- Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up(6 months)