Clinical trial NCT03925454: FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life
Official title: FREquent DIalysis and Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity and Quality of Life: an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: NxStage Medical
name: University of Portsmouth
First posted: 2019-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The start aims to recruit at the Wessex Kidney Centre, a regional renal and transplant centre based at Queen Alexandra Hospital, Portsmouth, UK (part of Portsmouth Hospitals NHS Trust). The patients involved in the study would have chosen their modality of dialysis in accordance with standard clinical practice and will not change any aspect of their treatment to meet the requirements of this study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pre- and post-dialysis levels of BNP
timeFrame: 12 months
measure: Pre- and post-dialysis levels of NTpro-BNP
timeFrame: 12 months
measure: Pre- and post-dialysis levels of TNT
timeFrame: 12 months
measure: Pre- and post-dialysis levels of Tnl
timeFrame: 12 months
measure: Left-ventricular mass
timeFrame: 12 months
measure: Ejection fraction
timeFrame: 12 months
measure: Left ventricular global strain
timeFrame: 12 months
measure: Right atrial volume
timeFrame: 12 months
measure: Integrated Back Scatter
timeFrame: 12 months
Secondary outcomes:
measure: Peripheral skeletal muscle oxygenation using near-infrared spectroscopy
timeFrame: 12 months
measure: Maximal cardiopulmonary exercise testing (CPET)
timeFrame: 12 months
measure: Breath-by-breath changes in pulmonary gas exchange and ventilation
timeFrame: 12 months
measure: Objective assessment of habitual physical activity using a triaxial
timeFrame: 12 months
measure: Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary
timeFrame: 12 months
measure: Blood pressure measued using NICOM sensor
timeFrame: 12 months
measure: Cardiac index measued using NICOM sensor
timeFrame: 12 months
measure: Stroke volume measued using NICOM sensor
timeFrame: 12 months
measure: Cardiac output measued using NICOM sensor
timeFrame: 12 months
measure: Total peripheral resistance measued using NICOM sensor
timeFrame: 12 months
measure: Cardiac power index measued using NICOM sensor
timeFrame: 12 months
measure: Concentration of pre and post dialysis Beta-2-microglobulin
timeFrame: 12 months
measure: Cncentration of pre-dialysis FGF-23
timeFrame: 12 months
measure: Cncentration of pre-dialysis High-sensitivity CRP
timeFrame: 12 months
measure: Cncentration of pre-dialysis Interleukin-6
timeFrame: 12 months
measure: Cncentration of pre-dialysis Interleukin-10
timeFrame: 12 months
measure: Urine creatinine level
timeFrame: 12 months
measure: Urine urea level
timeFrame: 12 months
measure: RAPA score
timeFrame: 12 months
measure: KDQoL-36 score
timeFrame: 12 months
measure: FACIT-F score
timeFrame: 12 months
measure: Recovery time
timeFrame: 12 months
measure: Lean tissue mass
timeFrame: 12 months
measure: fat mass
timeFrame: 12 months
measure: Extra/intracellular water
timeFrame: 12 months
measure: Total body water
timeFrame: 12 months
measure: Saliva flow rate
timeFrame: 12 months
measure: Change in number of antihypertensive agents
timeFrame: Over 12 months period
measure: Change in erythropoietin dosage
timeFrame: Over 12 months period
measure: Number of in-patient days with cause
timeFrame: Over 12 months period
measure: Major adverse cardiovascular events (MACE)
timeFrame: Over 12 months period
measure: All-cause and cardiovascular mortality
timeFrame: Over 12 months period
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
state: Hampshire
Study officials:
References: