FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life (FREDI-CAL)

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral skeletal muscle oxygenation using near-infrared spectroscopy	Pulmonary gas exchange analyser generated data file	12 months
Maximal cardiopulmonary exercise testing (CPET)	Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function	12 months
Breath-by-breath changes in pulmonary gas exchange and ventilation	Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function	12 months
Objective assessment of habitual physical activity using a triaxial	Triaxial accelerometer generated data file consist of time went to sleep and time of waking up	12 months
Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary	Triaxial accelerometer generated data file consist of time went to sleep and time of waking up	12 months
Blood pressure measued using NICOM sensor	Non-invasive haemodynamic measurements using NICOM sensor for blood pressure	12 months
Cardiac index measued using NICOM sensor	Non-invasive haemodynamic measurements using NICOM sensor for cardiac index	12 months
Stroke volume measued using NICOM sensor	Non-invasive haemodynamic measurements using NICOM sensor for stroke volume	12 months
Cardiac output measued using NICOM sensor	Non-invasive haemodynamic measurements using NICOM sensor for cardiac output	12 months
Total peripheral resistance measued using NICOM sensor	Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance	12 months
Cardiac power index measued using NICOM sensor	Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index	12 months
Concentration of pre and post dialysis Beta-2-microglobulin	Markers of inflammation and dialysis adequacy	12 months
Cncentration of pre-dialysis FGF-23	Markers of inflammation and dialysis adequacy	12 months
Cncentration of pre-dialysis High-sensitivity CRP	Markers of inflammation and dialysis adequacy	12 months
Cncentration of pre-dialysis Interleukin-6	Markers of inflammation and dialysis adequacy	12 months
Cncentration of pre-dialysis Interleukin-10	Markers of inflammation and dialysis adequacy	12 months
Urine creatinine level	Residual renal function	12 months
Urine urea level	Residual renal function	12 months
RAPA score	Derivered from RAPA questionnaire	12 months
KDQoL-36 score	Derivered from KDQoL-36 questionnaire	12 months
FACIT-F score	Derivered from FACIT-F questionnaire	12 months
Recovery time	Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session	12 months
Lean tissue mass	Hydration status through body composition monitoring	12 months
fat mass	Hydration status through body composition monitoring	12 months
Extra/intracellular water	Hydration status through body composition monitoring	12 months
Total body water	Hydration status through body composition monitoring	12 months
Saliva flow rate	Part of hydration status determiantion	12 months
Change in number of antihypertensive agents	Number of antihypertensive agents	Over 12 months period
Change in erythropoietin dosage	Erythropoietin dosage	Over 12 months period
Number of in-patient days with cause	Date of hospital admission and date of hospital discharge	Over 12 months period
Major adverse cardiovascular events (MACE)	Number of events considered a Major Adverse Cardiovascular Event	Over 12 months period
All-cause and cardiovascular mortality	Number of withdrawal Information: Death of patient	Over 12 months period

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: University of Portsmouth; NxStage Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): January 13, 2022

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: PHT/2017/122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No