FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life
- Conditions
- Kidney Failure
- Registration Number
- NCT03925454
- Lead Sponsor
- Portsmouth Hospitals NHS Trust
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ejection fraction 12 months Visual Ejection fraction, Biplane Ejection fraction
Pre- and post-dialysis levels of Tnl 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 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
Left ventricular global strain 12 months Average GLS
Right atrial volume 12 months Dertermine using echocardiogram
Pre- and post-dialysis levels of BNP 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 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 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 12 months Dertermine using echocardiogram
- Secondary Outcome Measures
Name Time Method Peripheral skeletal muscle oxygenation using near-infrared spectroscopy 12 months Pulmonary gas exchange analyser generated data file
Maximal cardiopulmonary exercise testing (CPET) 12 months Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
Breath-by-breath changes in pulmonary gas exchange and ventilation 12 months Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
Objective assessment of habitual physical activity using a triaxial 12 months Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary 12 months Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
Blood pressure measued using NICOM sensor 12 months Non-invasive haemodynamic measurements using NICOM sensor for blood pressure
Cardiac index measued using NICOM sensor 12 months Non-invasive haemodynamic measurements using NICOM sensor for cardiac index
Stroke volume measued using NICOM sensor 12 months Non-invasive haemodynamic measurements using NICOM sensor for stroke volume
Cardiac output measued using NICOM sensor 12 months Non-invasive haemodynamic measurements using NICOM sensor for cardiac output
Total peripheral resistance measued using NICOM sensor 12 months Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance
Cardiac power index measued using NICOM sensor 12 months Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index
Concentration of pre and post dialysis Beta-2-microglobulin 12 months Markers of inflammation and dialysis adequacy
Cncentration of pre-dialysis Interleukin-10 12 months Markers of inflammation and dialysis adequacy
Urine creatinine level 12 months Residual renal function
Urine urea level 12 months Residual renal function
RAPA score 12 months Derivered from RAPA questionnaire
KDQoL-36 score 12 months Derivered from KDQoL-36 questionnaire
FACIT-F score 12 months Derivered from FACIT-F questionnaire
Recovery time 12 months Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session
Lean tissue mass 12 months Hydration status through body composition monitoring
fat mass 12 months Hydration status through body composition monitoring
Extra/intracellular water 12 months Hydration status through body composition monitoring
Total body water 12 months Hydration status through body composition monitoring
Saliva flow rate 12 months Part of hydration status determiantion
Change in number of antihypertensive agents Over 12 months period Number of antihypertensive agents
Change in erythropoietin dosage Over 12 months period Erythropoietin dosage
Number of in-patient days with cause Over 12 months period Date of hospital admission and date of hospital discharge
Major adverse cardiovascular events (MACE) Over 12 months period Number of events considered a Major Adverse Cardiovascular Event
All-cause and cardiovascular mortality Over 12 months period Number of withdrawal Information: Death of patient
Cncentration of pre-dialysis FGF-23 12 months Markers of inflammation and dialysis adequacy
Cncentration of pre-dialysis High-sensitivity CRP 12 months Markers of inflammation and dialysis adequacy
Cncentration of pre-dialysis Interleukin-6 12 months Markers of inflammation and dialysis adequacy
Trial Locations
- Locations (1)
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
🇬🇧Portsmouth, Hampshire, United Kingdom