Clinical Investigation Plan Optimizing Fluid Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- intra-individual difference in TAFO between study start and study end
研究概览
简要总结
Title of study: Optimizing Fluid Status
Study code: HD-IIT-01-E
Study design: Prospective open design in study centre at two locations
Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload and dry weight
Aim of the study: To improve the fluid status in chronic HD patients (measured as OH (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now, the BCM was occasionally applied in both locations of the study centre.
Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the:
- time averaged fluid overload (TAFO),
- proportion of patients with severe overhydration OH > 2.5 L,or OH/ECW > 15 %)
- proportion of dehydrated patients (OH < -1.0 L, or OH < -7 %),
- mean overhydration,
- variance of overhydration,
- time outside the reference range (-1.0L < OH < 2.5L).
Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM, Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ; Body Composition Monitor BCM ; Data management software / database system NephroLink Disposables used in this study: BVM blood lines and BCM electrodes
Patients: 60 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Chronic renal failure stage V
- •Treatment thrice weekly with HD or on-line HDF for at least 6 months prior to inclusion
- •Ability to understand the nature and requirements of the study
- •Age: at least 18 years
- •Signed informed consent.
排除标准
- •Interventional clinical study during the preceding 30 days or previous participation in the same study
- •Acute or chronic infection (HIV, Hepatitis B or C, ...)
- •Severe disease (malignant tumour, tuberculosis ...)
- •Usually single needle HD
- •Problems with shunt or high recirculation,
- •Severe intra-dialytic blood pressure instability in the last month
- •Instable angina pectoris
- •Major amputation at arm or leg, or a pacemaker.
结局指标
主要结局
intra-individual difference in TAFO between study start and study end
时间窗: 3 months
次要结局
- Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)(3 months)
- Comparison between start and end of treatment will be performed for number of patients in target range (TAFO from -0.2 L to 1.3 L)(3 months)
- SF 36 total score and sub-scores as calculated according to official guidelines,(3 months)
- BNP(3 months)
- Blood pressure(3 months)
- laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).(3 months)
- Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)(3 months)
- Change from baseline in intra-dialytic events (hypotension, cramps)(3 months)
- Change from baseline in Residual Renal Function(3 months)
- Hospitalisation(3 months)
研究者
Francisco Maduell
Principal Investigator; Head of Dialysis Section
Hospital Clinic of Barcelona