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

Portsmouth Hospitals NHS Trust30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Kidney Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 12 months

Ejection fraction

Visual Ejection fraction, Biplane Ejection fraction

Time frame: 12 months

Left ventricular global strain

Average GLS

Time frame: 12 months

Right atrial volume

Dertermine using echocardiogram

Time frame: 12 months

Integrated Back Scatter

Dertermine using echocardiogram

Time frame: 12 months

Secondary Outcomes

Peripheral skeletal muscle oxygenation using near-infrared spectroscopy

Pulmonary gas exchange analyser generated data file

Time frame: 12 months

Maximal cardiopulmonary exercise testing (CPET)

Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months

Blood pressure measued using NICOM sensor

Non-invasive haemodynamic measurements using NICOM sensor for blood pressure

Time frame: 12 months

Cardiac index measued using NICOM sensor

Non-invasive haemodynamic measurements using NICOM sensor for cardiac index

Time frame: 12 months

Stroke volume measued using NICOM sensor

Non-invasive haemodynamic measurements using NICOM sensor for stroke volume

Time frame: 12 months

Data from ClinicalTrials.gov

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Cardiac output measued using NICOM sensor

Non-invasive haemodynamic measurements using NICOM sensor for cardiac output

Time frame: 12 months

Total peripheral resistance measued using NICOM sensor

Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance

Time frame: 12 months

Cardiac power index measued using NICOM sensor

Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index

Time frame: 12 months

Concentration of pre and post dialysis Beta-2-microglobulin