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Completed

NCT Number: NCT03925454

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

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.

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pre- and post-dialysis levels of BNP

    Time frame: 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.

  2. Pre- and post-dialysis levels of NTpro-BNP

    Time frame: 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.

  3. Pre- and post-dialysis levels of TNT

    Time frame: 12 months

    Troponin-T (TNT) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples

  4. Pre- and post-dialysis levels of Tnl

    Time frame: 12 months

    Troponin-L (Tnl) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.

  5. Left-ventricular mass

    Time frame: 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

  6. Ejection fraction

    Time frame: 12 months

    Visual Ejection fraction, Biplane Ejection fraction

  7. Left ventricular global strain

    Time frame: 12 months

    Average GLS

  8. Right atrial volume

    Time frame: 12 months

    Dertermine using echocardiogram

  9. Integrated Back Scatter

    Time frame: 12 months

    Dertermine using echocardiogram

Secondary outcomes

  1. Peripheral skeletal muscle oxygenation using near-infrared spectroscopy

    Time frame: 12 months

    Pulmonary gas exchange analyser generated data file

  2. Maximal cardiopulmonary exercise testing (CPET)

    Time frame: 12 months

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

  3. Breath-by-breath changes in pulmonary gas exchange and ventilation

    Time frame: 12 months

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

  4. Objective assessment of habitual physical activity using a triaxial

    Time frame: 12 months

    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up

  5. Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary

    Time frame: 12 months

    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up

  6. Blood pressure measued using NICOM sensor

    Time frame: 12 months

    Non-invasive haemodynamic measurements using NICOM sensor for blood pressure

  7. Cardiac index measued using NICOM sensor

    Time frame: 12 months

    Non-invasive haemodynamic measurements using NICOM sensor for cardiac index

  8. Stroke volume measued using NICOM sensor

    Time frame: 12 months

    Non-invasive haemodynamic measurements using NICOM sensor for stroke volume

  9. Cardiac output measued using NICOM sensor

    Time frame: 12 months

    Non-invasive haemodynamic measurements using NICOM sensor for cardiac output

  10. Total peripheral resistance measued using NICOM sensor

    Time frame: 12 months

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

  11. Cardiac power index measued using NICOM sensor

    Time frame: 12 months

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

  12. Concentration of pre and post dialysis Beta-2-microglobulin

    Time frame: 12 months

    Markers of inflammation and dialysis adequacy

  13. Cncentration of pre-dialysis FGF-23

    Time frame: 12 months

    Markers of inflammation and dialysis adequacy

  14. Cncentration of pre-dialysis High-sensitivity CRP

    Time frame: 12 months

    Markers of inflammation and dialysis adequacy

  15. Cncentration of pre-dialysis Interleukin-6

    Time frame: 12 months

    Markers of inflammation and dialysis adequacy

  16. Cncentration of pre-dialysis Interleukin-10

    Time frame: 12 months

    Markers of inflammation and dialysis adequacy

  17. Urine creatinine level

    Time frame: 12 months

    Residual renal function

  18. Urine urea level

    Time frame: 12 months

    Residual renal function

  19. RAPA score

    Time frame: 12 months

    Derivered from RAPA questionnaire

  20. KDQoL-36 score

    Time frame: 12 months

    Derivered from KDQoL-36 questionnaire

  21. FACIT-F score

    Time frame: 12 months

    Derivered from FACIT-F questionnaire

  22. Recovery time

    Time frame: 12 months

    Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session

  23. Lean tissue mass

    Time frame: 12 months

    Hydration status through body composition monitoring

  24. fat mass

    Time frame: 12 months

    Hydration status through body composition monitoring

  25. Extra/intracellular water

    Time frame: 12 months

    Hydration status through body composition monitoring

  26. Total body water

    Time frame: 12 months

    Hydration status through body composition monitoring

  27. Saliva flow rate

    Time frame: 12 months

    Part of hydration status determiantion

  28. Change in number of antihypertensive agents

    Time frame: Over 12 months period

    Number of antihypertensive agents

  29. Change in erythropoietin dosage

    Time frame: Over 12 months period

    Erythropoietin dosage

  30. Number of in-patient days with cause

    Time frame: Over 12 months period

    Date of hospital admission and date of hospital discharge

  31. Major adverse cardiovascular events (MACE)

    Time frame: Over 12 months period

    Number of events considered a Major Adverse Cardiovascular Event

  32. All-cause and cardiovascular mortality

    Time frame: Over 12 months period

    Number of withdrawal Information: Death of patient

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • NxStage Medical
  • University of Portsmouth

Registry information

Official study title

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

Acronym: FREDI-CAL

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2019
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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