FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-Centre Haemodiafiltration (ICHDF) Group<br>Participants undergoing ICHDF treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study. | |
| Home HaemoDialysis (HHD) Group<br>Participants undergoing HHD treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- and post-dialysis levels of BNP | Brain Natriuretic Peptide (BNP) is one of the biomarkers of myocardial damage, it's level will be measued in EDTA anticoagulated participants' blood samples. | 12 months | 
| Pre- and post-dialysis levels of NTpro-BNP | 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. | 12 months | 
| Pre- and post-dialysis levels of TNT | Troponin-T (TNT) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples | 12 months | 
| Pre- and post-dialysis levels of Tnl | Troponin-L (Tnl) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples. | 12 months | 
| Left-ventricular mass | Left-ventricular mass is a well-established measure that can independently predict adverse cardiovascular events and will be determined using echocardiogram in this study | 12 months | 
| Ejection fraction | Visual Ejection fraction, Biplane Ejection fraction | 12 months | 
| Left ventricular global strain | Average GLS | 12 months | 
| Right atrial volume | Dertermine using echocardiogram | 12 months | 
| Integrated Back Scatter | Dertermine using echocardiogram | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral skeletal muscle oxygenation using near-infrared spectroscopy | Pulmonary gas exchange analyser generated data file | 12 months | 
| Maximal cardiopulmonary exercise testing (CPET) | Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function | 12 months | 
| Breath-by-breath changes in pulmonary gas exchange and ventilation | Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function | 12 months | 
| Objective assessment of habitual physical activity using a triaxial | Triaxial accelerometer generated data file consist of time went to sleep and time of waking up | 12 months | 
| Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary | Triaxial accelerometer generated data file consist of time went to sleep and time of waking up | 12 months | 
| Blood pressure measued using NICOM sensor | Non-invasive haemodynamic measurements using NICOM sensor for blood pressure | 12 months | 
| Cardiac index measued using NICOM sensor | Non-invasive haemodynamic measurements using NICOM sensor for cardiac index | 12 months | 
| Stroke volume measued using NICOM sensor | Non-invasive haemodynamic measurements using NICOM sensor for stroke volume | 12 months | 
| Cardiac output measued using NICOM sensor | Non-invasive haemodynamic measurements using NICOM sensor for cardiac output | 12 months | 
| Total peripheral resistance measued using NICOM sensor | Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance | 12 months | 
| Cardiac power index measued using NICOM sensor | Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index | 12 months | 
| Concentration of pre and post dialysis Beta-2-microglobulin | Markers of inflammation and dialysis adequacy | 12 months | 
| Cncentration of pre-dialysis FGF-23 | Markers of inflammation and dialysis adequacy | 12 months | 
| Cncentration of pre-dialysis High-sensitivity CRP | Markers of inflammation and dialysis adequacy | 12 months | 
| Cncentration of pre-dialysis Interleukin-6 | Markers of inflammation and dialysis adequacy | 12 months | 
| Cncentration of pre-dialysis Interleukin-10 | Markers of inflammation and dialysis adequacy | 12 months | 
| Urine creatinine level | Residual renal function | 12 months | 
| Urine urea level | Residual renal function | 12 months | 
| RAPA score | Derivered from RAPA questionnaire | 12 months | 
| KDQoL-36 score | Derivered from KDQoL-36 questionnaire | 12 months | 
| FACIT-F score | Derivered from FACIT-F questionnaire | 12 months | 
| Recovery time | Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session | 12 months | 
| Lean tissue mass | Hydration status through body composition monitoring | 12 months | 
| fat mass | Hydration status through body composition monitoring | 12 months | 
| Extra/intracellular water | Hydration status through body composition monitoring | 12 months | 
| Total body water | Hydration status through body composition monitoring | 12 months | 
| Saliva flow rate | Part of hydration status determiantion | 12 months | 
| Change in number of antihypertensive agents | Number of antihypertensive agents | Over 12 months period | 
| Change in erythropoietin dosage | Erythropoietin dosage | Over 12 months period | 
| Number of in-patient days with cause | Date of hospital admission and date of hospital discharge | Over 12 months period | 
| Major adverse cardiovascular events (MACE) | Number of events considered a Major Adverse Cardiovascular Event | Over 12 months period | 
| All-cause and cardiovascular mortality | Number of withdrawal Information: Death of patient | Over 12 months period |