Kidney Failure
Conditions
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.
Interventions
None listed
Sponsors
NxStage Medical
University of Portsmouth
Portsmouth Hospitals NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Ejection fraction | 12 months | Visual Ejection fraction, Biplane Ejection fraction |
| Left ventricular global strain | 12 months | Average GLS |
| Right atrial volume | 12 months | Dertermine using echocardiogram |
| Integrated Back Scatter | 12 months | Dertermine using echocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| Peripheral skeletal muscle oxygenation using near-infrared spectroscopy | 12 months | Pulmonary gas exchange analyser generated data file |
| 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 |
| Total body water | 12 months | Hydration status through body composition monitoring |
| 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 |
Countries
United Kingdom
Outcome results
None listed