Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes in the cardiac biomarkers from baseline to during and after high-flux hemodialysis and post-dilution hemodiafiltration.
研究概览
简要总结
This randomized, crossover study aims to investigate the intradialytic kinetics of selected cardiac biomarkers in patients with end-stage renal disease treated with dialysis. The cardiac biomarkers of interest include high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide, and a novel cardiac biomarker named secretoneurin.
In 24 patients treated with maintenance hemodialysis, the study will compare high-flux hemodialysis (HD) with post-dilution hemodiafiltration (HDF) to investigate:
- Baseline concentrations and week-to-week plasma variations of the cardiac biomarkers.
- Changes in the plasma concentrations of the cardiac biomarkers during high-flux HD and post-dilution HDF.
- Dialyzer clearance of the cardiac biomarkers in high-flux HD and post-dilution HDF.
- Adherence of the cardiac biomarkers to the dialyzer membrane.
- Concentrations of the cardiac biomarkers 30 minutes post-dialysis to investigate a potential rebound effect.
Additionally, a sub-study of 24 patients treated with peritoneal dialysis will investigate the baseline concentrations and week-to-week plasma variations of the same cardiac biomarkers.
详细描述
Patients treated with maintenance hemodialysis:
Single-center, randomized, crossover study with 24 participants. The study will investigate the effect of high-flux HD (using the FX CorDiax 100 dialyzer) and post-dilution HDF (using the FX CorDiax 1000 dialyzer) on the intradialytic kinetics of selected cardiac biomarkers. The study will not be blinded, but the order of the interventions will be randomized. The two dialysis sessions will be conducted on the same weekday. Between the two interventions, the patient will have a wash-out period of 1-3 weeks with standard dialysis treatment.
On both trial days, the following dialysis settings will be the same for each individual patient:
- The dialysis sessions will last 4 hours.
- The same dialysis machine will be used, either the Fresenius Medical Care 5008 or 6008 CAREsystem machine.
- Same vascular access will be used.
- The composition of electrolytes in the dialysate will be the same.
- Blood flow rate will be >300 mL per minute and consistent.
- Dialysate flow rate will be 500 mL per minute.
- Ultrafiltration rate will be constant aiming at dry weight.
- Routine anticoagulation protocol will be unchanged, but consistent on both trial days.
- Routine dialysate temperature will be unchanged, but consistent on both trial days.
On both trial days, different baseline characteristics will be gathered, including demographic data, clinical data, dialysis characteristics, and routine blood samples. Blood samples, for the analysis of the selected cardiac biomarkers, will be collected:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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 of 18 years or older.
- •Clinically stable patients with end-stage renal disease treated with maintenance hemodialysis or peritoneal dialysis.
- •Regarding patients treated with hemodialysis: Dialysis access with an arteriovenous fistula and able to maintain a blood flow rate >300 mL.
排除标准
- •- Not able to understand or sign informed consent.
结局指标
主要结局
Changes in the cardiac biomarkers from baseline to during and after high-flux hemodialysis and post-dilution hemodiafiltration.
时间窗: Before the start of a dialysis session; after 10, 30, 60, 120, 180, and 240 minutes of dialysis; and 5-30 min. after dialysis cessation.
Changes in the selected cardiac biomarkers from baseline, to after 10, 30, 60, 120, 180, and 240 minutes of dialysis, and 5-30 min. after dialysis cessation in both high-flux hemodialysis and post-dilution hemodiafiltration. The two dialysis modalities will be compared.
次要结局
- Dialyzer clearance of the cardiac biomarkers in high-flux hemodialysis and post-dilution hemodiafiltration.(After 120 minutes of dialysis.)
- Adherence of the cardiac biomarkers to the dialyzer membrane in high-flux hemodialysis and post-dilution hemodiafiltration.(After 120 minutes of dialysis.)
研究者
Caroline Hundborg Liboriussen
Principal Investigator, Medical Doctor, and PhD student at the Department of Nephrology, Aalborg University Hospital, Denmark
Aalborg University Hospital