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

NCT03925454 | Completed

• 1 other identifier: PHT/2017/122
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (9)

• Pre- and post-dialysis levels of BNP

  Brain Natriuretic Peptide (BNP) is one of the biomarkers of myocardial damage, it's level will be measued in EDTA anticoagulated participants' blood samples.

  12 months

• Pre- and post-dialysis levels of NTpro-BNP

  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.

  12 months

• Pre- and post-dialysis levels of TNT

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

  12 months

• Pre- and post-dialysis levels of Tnl

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

  12 months

• Left-ventricular mass

  Left-ventricular mass is a well-established measure that can independently predict adverse cardiovascular events and will be determined using echocardiogram in this study

  12 months

• Ejection fraction

  Visual Ejection fraction, Biplane Ejection fraction

  12 months

• Left ventricular global strain

  Average GLS

  12 months

• Right atrial volume

  Dertermine using echocardiogram

  12 months

• Integrated Back Scatter

  Dertermine using echocardiogram

  12 months

Secondary Outcomes (32)

• Peripheral skeletal muscle oxygenation using near-infrared spectroscopy

  12 months

• Maximal cardiopulmonary exercise testing (CPET)

  12 months

• Breath-by-breath changes in pulmonary gas exchange and ventilation

  12 months

• Objective assessment of habitual physical activity using a triaxial

  12 months

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

  12 months

Study Arms (2)

In-Centre Haemodiafiltration (ICHDF) Group

Participants undergoing ICHDF treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study.

Home HaemoDialysis (HHD) Group

Participants undergoing HHD treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• NxStage Medical: collaborator
• University of Portsmouth: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 24, 2019
• Study Start: March 19, 2019
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)