NCT01515878Unknown4 期
Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 396
- 试验地点
- 5
- 主要终点
- Cardiovascular events
研究概览
简要总结
It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 65 years old
- •Arterial Hypertension: predialysis SBP >140 mmHg and/or DBP >90 mmHg in at least 50% over the previous month dialysis sessions or receiving at least one antihypertensive pharmacological drug including diuretics, disregarded blood pressure value
- •On a three times per week hemodialysis schedule
- •Time on hemodialysis less than 6 months
- •Able to measure their blood pressure at home (by themselves or with the aid of the care giver)
- •Signed informed consent
排除标准
- •Active neoplastic disease
- •Mental illness
- •Single needle treatment
- •Inability, as judged by the investigator, to follow or understand the protocol instructions
- •Blood flow rate less than 200 mL/min
- •Patients who at the time of recruitment need clinical indication for special renal replacement therapies and/or on treatment with one of the following modalities: HDF or similar diffusive-convective therapies, treatment time >5h, blood temperature control, isolated UF profiling of Na/UFR
- •Patients with a life expectancy shorter than 6 months
- •Patients in a list for transplant within the next 6 months
- •Predialysis Hemoglobin level greater than 13.5 g/dl
- •History of major cardiovascular events during run in period
结局指标
主要结局
Cardiovascular events
时间窗: 36 months
The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events
次要结局
- Dry weight management(36 months)
- Cardiovascular morbidity(36 months)
- Blood pressure control(36 months)
- Quality of life and dialysis tolerance evaluated with questionnaire.(36 months)
研究者
Antonio Santoro
Professor, MD, Chief of Nephrology
IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Can the beneficial effect of Hemocontrol on blood pressure during dialysis be explained by higher blood levels of vasopressin. A pilot study.NL-OMON35305Dialyse Centrum Groningen12
Unknown
不适用
Validation of Continuous Noninvasive Haemoglobin Monitoring by the Radical 7 Pulse CO-Oximetry Monitor After in Vivo Adjustment.Sphb Haemoglobin in Vivo ValidationNCT02399488Hospital Universitario Doctor Peset60
已完成
不适用
Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 ClearingHumoral Immune AlterationsChronic Renal FailureNCT01066559University Hospital, Bordeaux27
终止
4 期
Tight Hemodynamic Control in Patients Who Are Chronically on MetoprololVascular DiseaseAnginaCardiac DiseaseHypertensionNCT01404767University Health Network, Toronto20
招募中
不适用
Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma PatientsTraumaNCT04911465University of Colorado, Denver300