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临床试验/NCT03925454
NCT03925454已完成不适用

FREquent DIalysis and Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity and Quality of Life: an Observational Pilot Study

Portsmouth Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Pre- and post-dialysis levels of Tnl

研究概览

简要总结

Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. The rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. It can also cause problems with the heart in the long-term.

In recent years, individuals requiring dialysis have been able to choose between standard ICHDF or having haemodialysis at home (HHD) using a convenient table top machine called NxStage System One. This device is used more frequently than in ICHDF and for shorter sessions. As a result, the amount of fluid removed during each session is less than with ICHDF. This may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. It may also reduce the time taken to recover from any symptoms experienced after dialysis.

Over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent HHD will be studied and the results will be compared with a group of patients receiving ICHDF. The study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. In addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.

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

入选标准

  • Receiving HHD or ICHDF for more than 3 months and less than 36 months.
  • Haemoglobin equal to or greater than100 g/L at enrolment.
  • Willing and physically able to undertake the study assessments/tests
  • Willing to provide blood for storage and future analysis
  • Able to give informed consent

排除标准

  • Living donor transplant or change to peritoneal dialysis planned
  • Physical assessments contraindicated for the following clinical reasons
  • Acute Coronary Syndrome (ACS) within the last 3 months (chest pain, ECG changes or typical biomarker elevation).
  • Any current uncontrolled cardiac dysrhythmias causing symptoms (chest pain, palpitations, syncope or dizziness)
  • Symptomatic aortic stenosis
  • New York Heart Association grade IV Heart failure
  • Severe chronic obstructive pulmonary disease
  • Acute pulmonary embolus or pulmonary infarction in the last 3 months
  • Current acute myocarditis or pericarditis
  • Suspected or known dissecting aneurysm
  • Acute systemic infection, accompanied by fever, body aches or swollen lymph glands
  • Pregnancy
  • Life expectancy of less than twelve months

结局指标

主要结局

Pre- and post-dialysis levels of Tnl

时间窗: 12 months

Troponin-L (Tnl) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.

Left-ventricular mass

时间窗: 12 months

Left-ventricular mass is a well-established measure that can independently predict adverse cardiovascular events and will be determined using echocardiogram in this study

Ejection fraction

时间窗: 12 months

Visual Ejection fraction, Biplane Ejection fraction

Left ventricular global strain

时间窗: 12 months

Average GLS

Right atrial volume

时间窗: 12 months

Dertermine using echocardiogram

Pre- and post-dialysis levels of BNP

时间窗: 12 months

Brain Natriuretic Peptide (BNP) is one of the biomarkers of myocardial damage, it's level will be measued in EDTA anticoagulated participants' blood samples.

Pre- and post-dialysis levels of NTpro-BNP

时间窗: 12 months

N-terminal pro-brain natriuretic peptide (NTpro-BNP) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.

Pre- and post-dialysis levels of TNT

时间窗: 12 months

Troponin-T (TNT) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples

Integrated Back Scatter

时间窗: 12 months

Dertermine using echocardiogram

次要结局

  • All-cause and cardiovascular mortality(Over 12 months period)
  • Peripheral skeletal muscle oxygenation using near-infrared spectroscopy(12 months)
  • Maximal cardiopulmonary exercise testing (CPET)(12 months)
  • Breath-by-breath changes in pulmonary gas exchange and ventilation(12 months)
  • Objective assessment of habitual physical activity using a triaxial(12 months)
  • Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary(12 months)
  • Blood pressure measued using NICOM sensor(12 months)
  • Cardiac index measued using NICOM sensor(12 months)
  • Stroke volume measued using NICOM sensor(12 months)
  • Cardiac output measued using NICOM sensor(12 months)
  • Total peripheral resistance measued using NICOM sensor(12 months)
  • Cardiac power index measued using NICOM sensor(12 months)
  • Concentration of pre and post dialysis Beta-2-microglobulin(12 months)
  • Cncentration of pre-dialysis Interleukin-10(12 months)
  • Urine creatinine level(12 months)
  • Urine urea level(12 months)
  • RAPA score(12 months)
  • KDQoL-36 score(12 months)
  • FACIT-F score(12 months)
  • Recovery time(12 months)
  • Lean tissue mass(12 months)
  • fat mass(12 months)
  • Extra/intracellular water(12 months)
  • Total body water(12 months)
  • Saliva flow rate(12 months)
  • Change in number of antihypertensive agents(Over 12 months period)
  • Change in erythropoietin dosage(Over 12 months period)
  • Number of in-patient days with cause(Over 12 months period)
  • Major adverse cardiovascular events (MACE)(Over 12 months period)
  • Cncentration of pre-dialysis FGF-23(12 months)
  • Cncentration of pre-dialysis High-sensitivity CRP(12 months)
  • Cncentration of pre-dialysis Interleukin-6(12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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