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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03925454

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted April 29, 2019

Study Description

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.

  • Condition or Disease:Kidney Failure
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 40 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: FREquent DIalysis and Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity and Quality of Life: an Observational Pilot Study
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: November 2020
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 1. Total body water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • 2. Saliva flow rate [ Time Frame: 12 months ]
    Part of hydration status determiantion
  • 3. Change in number of antihypertensive agents [ Time Frame: Over 12 months period ]
    Number of antihypertensive agents
  • 4. Change in erythropoietin dosage [ Time Frame: Over 12 months period ]
    Erythropoietin dosage
  • 5. Extra/intracellular water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • 6. Peripheral skeletal muscle oxygenation using near-infrared spectroscopy [ Time Frame: 12 months ]
    Pulmonary gas exchange analyser generated data file
  • 7. 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
  • 8. 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
  • 9. 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
  • 10. 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
  • 11. Blood pressure measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for blood pressure
  • 12. Cardiac index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac index
  • 13. Stroke volume measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for stroke volume
  • 14. Cardiac output measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac output
  • 15. Total peripheral resistance measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance
  • 16. Cardiac power index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index
  • 17. Concentration of pre and post dialysis Beta-2-microglobulin [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • 18. Cncentration of pre-dialysis FGF-23 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • 19. Cncentration of pre-dialysis High-sensitivity CRP [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • 20. Cncentration of pre-dialysis Interleukin-6 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • 21. Cncentration of pre-dialysis Interleukin-10 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • 22. Urine creatinine level [ Time Frame: 12 months ]
    Residual renal function
  • 23. Urine urea level [ Time Frame: 12 months ]
    Residual renal function
  • 24. RAPA score [ Time Frame: 12 months ]
    Derivered from RAPA questionnaire
  • 25. KDQoL-36 score [ Time Frame: 12 months ]
    Derivered from KDQoL-36 questionnaire
  • 26. FACIT-F score [ Time Frame: 12 months ]
    Derivered from FACIT-F questionnaire
  • 27. Recovery time [ Time Frame: 12 months ]
    Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session
  • 28. Lean tissue mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • 29. fat mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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

Contacts and Locations
Contacts
Locations

United Kingdom, Hampshire
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth

Sponsors and Collaborators

Portsmouth Hospitals NHS Trust

NxStage Medical

University of Portsmouth

More Information
  • Responsible Party: Portsmouth Hospitals NHS Trust
  • ClinicalTrials.gov Identifier: NCT03925454 History of Changes
  • Other Study ID Numbers: PHT/2017/122
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 29, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: All data will be stored anonymously once entered onto the case report form and data management database. The database will be utilised to safely and securely handle all study data and to minimise any potential risks associated with data collection. Any identifiable data, such as participant medical notes, will be kept confidential in accordance with the Caldicott Principles.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Renal Insufficiency