In-centre extended nocturnal haemodialysis: the effects on cardiovascular structure and physical function

Maintenance In-centre nocturnal haemoDialysis: a feasibility study iNvestIGating the effects on cardiac structure and pHysical funcTion in comparison to conventional treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16672784

Enrollment

Registered

2015-07-27

Start date

2015-07-20

Completion date

Unknown

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Renal disorders

Interventions

Intervention arm: Patients interested in extended hours dialysis in a dialysis unit overnight and consenting to participation in the trial will switch from conventional daytime treatment Control arm:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Be a prevalent haemodialysis patient for more than three months 2. Age 18 years or older 3. Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. Unable to undergo CMR scanning (metal implants / prostheses, claustrophobia etc.) 2. Age <18 years 3. Unable or unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame
As this is a feasibility study designed to inform future trial development, no single primary outcome will be selected. All outcomes collected are listed below: 1. Left ventricular mass in grams (using cardiac MR) 2. Cardiac output and other haemodynamic variables measured using the noninvasive cardiac output monitor (NICOM) 3. Physical performance, specifically gait speed, balance, muscular power and muscular endurance, as assessed by the short physical performance battery and the sit-to-stand 60 tests. 4. Habitual activity levels as assessed by accelerometery 5. Quality of life and perceived physical function assessed using short form 12 questionnaire, palliative outcome scale-symptoms renal questionnaire, Pittsburgh sleep quality index questionnaire, functional assessment of chronic illness treatment fatigue questionnaire, Leicester dialysis patient physical activity questionnaire. 6. Diet quality assessed by either dietary recall interview or food diary 7. Markers of malnutrition, inflammation, cardiovascular dysfunction a and cardiovascular risk assessed by analysis of blood sample 8. Body composition (including lean tissue, fat tissue, fluid overload, body cell mass) assessed by bioimpedance spectroscopy (using body composition monitor)	—

Measure

Time frame

As this is a feasibility study designed to inform future trial development, no single primary outcome will be selected. All outcomes collected are listed below: 1. Left ventricular mass in grams (using cardiac MR) 2. Cardiac output and other haemodynamic variables measured using the noninvasive cardiac output monitor (NICOM) 3. Physical performance, specifically gait speed, balance, muscular power and muscular endurance, as assessed by the short physical performance battery and the sit-to-stand 60 tests. 4. Habitual activity levels as assessed by accelerometery 5. Quality of life and perceived physical function assessed using short form 12 questionnaire, palliative outcome scale-symptoms renal questionnaire, Pittsburgh sleep quality index questionnaire, functional assessment of chronic illness treatment fatigue questionnaire, Leicester dialysis patient physical activity questionnaire. 6. Diet quality assessed by either dietary recall interview or food diary 7. Markers of malnutrition, inflammation, cardiovascular dysfunction a and cardiovascular risk assessed by analysis of blood sample 8. Body composition (including lean tissue, fat tissue, fluid overload, body cell mass) assessed by bioimpedance spectroscopy (using body composition monitor)

—

Secondary

Measure	Time frame
Please see Primary outcome measures section.	—

Countries

England, United Kingdom

Contacts

Public ContactDarren Churchward

dc262@le.ac.uk+44 (0)116 258 4346

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026