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

NCT ID: NCT03925454

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2022-01-13

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NxStage Medical

OTHER

Sponsor Role: collaborator

University of Portsmouth

OTHER

Sponsor Role: collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Countries

United Kingdom

Other Identifiers

PHT/2017/122

Identifier Type: -

Identifier Source: org_study_id