Condition category
Urological and Genital Diseases
Date applied
16/07/2015
Date assigned
27/07/2015
Last edited
05/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with established renal failure usually undergo haemodialysis for four hours, three times a week, in purpose-built units. This regime tends to place large strain on the heart and body. This strain can result in a number of different symptoms including dizziness, cramps and breathlessness. Haemodialysis itself causes the heart to enlarge and not work properly. In addition to this, most patients on dialysis are known to have very sedentary lifestyles due to the time commitments of their treatment, the nature of renal disease and related illnesses.
Extending dialysis sessions has been shown as one way of reducing the symptoms patients’ experience. This also reduces the strain on the patient’s heart and may improve heart health. One potential way to provide longer sessions is to conduct the haemodialysis sessions overnight and this has the added benefit of freeing up time during the day. Currently the Leicester General Hospital is the only NHS centre in the UK to offer nocturnal haemodialysis sessions, in a hospital setting.
Some previous research by other groups has looked at how receiving dialysis overnight in dialysis units affects the heart. However they have not used the gold standard imaging techniques. Furthermore, no one has yet looked at the effects of nocturnal dialysis on physical function and activity levels. The aim of the study is to compare a thrice weekly in-centre nocturnal regime to the conventional four hour thrice weekly regime.
This exploratory study will use cardiac magnetic resonance imaging (the gold standard technique) to look at how nocturnal dialysis affects the heart. Additionally, we will use simple, validated methods to assess physical function and activity levels. We will collect data on body composition, nutrition, blood biochemistry and markers of inflammation, to look at associations between these results as well as with physical function and activity levels. We will also collect information on quality of life, sleep quality and symptom burden. All the outcomes collected will provide us with high quality or new information that will help in the design of larger studies in the future.

Who can participate?
Adult patients on haemodialysis for more than three months.

What does the study involve?
There are two groups of participants: the intervention group and the control group.
In the intervention group, participants interested in extended hours dialysis in a dialysis unit overnight will switch from conventional daytime treatment to extended treatment overnight.
The control group will be made of participants on conventional day time treatment, who are matched to intervention patients and do not want to undergo extended treatment overnight.

What are the possible benefits and risks of participating?
Patients who receive extended treatment times in the overnight haemodialysis programme may expect to see improvements in their physical and psychological health. There are no other anticipated benefits to taking part in the research.

Where is the study run from?
Leicester General Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2014 to July 2016

Who is funding the study?
Van Geest Heart and Cardiovascular Research Fund, Leicester (UK)

Who is the main contact?
Mr Darren Churchward
dc262@le.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Darren Churchward

ORCID ID

http://orcid.org/0000-0003-4674-186X

Contact details

Unversity of Leicester Academic Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4346
dc262@le.ac.uk

Type

Scientific

Additional contact

Dr James Burton

ORCID ID

http://orcid.org/0000-0003-1176-7592

Contact details

University of Leicester Academic Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4346
jb343@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UNOLE 0528

Study information

Scientific title

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

Acronym

MIDNIGHT

Study hypothesis

1. Cardiac structure and function, as measured by CMR and NICOM, will improve in haemodialysis patients who switch from a conventional four hour thrice weekly regime to a thrice weekly in-centre nocturnal regime compared to patients who remain on conventional four hour thrice weekly dialysis.
2. Physical function, as measured by the short physical performance battery and sit-to-stand 60, will improve in haemodialysis patients who switch from a conventional four hour thrice weekly regime to a thrice weekly in-centre nocturnal regime compared to patients who remain on conventional four hour thrice weekly dialysis.
3. The time spent physically active, as measured by accelerometry, will improve in haemodialysis patients who switch from a conventional four hour thrice weekly regime to a thrice weekly in-centre nocturnal regime compared to patients who remain on conventional four hour thrice weekly dialysis.
4. Quality of life, as measured by validated questionnaires will improve in haemodialysis patients who switch from a conventional four hour thrice weekly regime to a thrice weekly in-centre nocturnal regime compared to patients who remain on conventional four hour thrice weekly dialysis.
5. Body composition and nutritional status, as measured by bioelectrical impedance analysis and diet recall, will improve in haemodialysis patients who switch from a conventional four hour thrice weekly regime to a thrice weekly in-centre nocturnal regime compared to patients who remain on conventional four hour thrice weekly dialysis.
6. Inflammatory and biochemical markers including, IL-6, IL-10, CRP, phosphate, calcium, and other markers measured monthly, will improve in haemodialysis patients who switch from a conventional four hour thrice weekly regime to a thrice weekly in-centre nocturnal regime compared to patients who remain on conventional four hour thrice weekly dialysis.
7. Dialysis efficacy will improve in haemodialysis patients who switch from a conventional four hour thrice weekly regime to a thrice weekly in-centre nocturnal regime compared to patients who remain on conventional four hour thrice weekly dialysis.

Ethics approval

NRES Committee East Midlands- Northampton, 09/07/2015, REC ref: 15/EM/0268

Study design

Non-randomised controlled feasability trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders

Intervention

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: Patients on conventional day time treatment, who are matched to intervention patients and do not want to undergo extended treatment overnight, will be recruited.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 outcome measures

Please see Primary outcome measures section.

Overall trial start date

01/09/2014

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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

Recruitment start date

20/07/2015

Recruitment end date

01/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Department of Infection, Immunity and Inflammation Maurice Shock Medical Sciences Building University Road
Leicester
LE1 9HN
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

University Road
Leicester
LE1 7RH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Van Geest Heart and Cardiovascular Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will look to publish data relating to all outcome measures, as well as a methodology paper of the study protocol. Results will be included in a research newsletter that is given to patients to inform them of developments made by our research team and promote the research we are doing.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 11/01/2016 the recruitment end date was changed from 01/12/2015 to 01/04/2016. The registration was initiated on 16/07/2015 and finalised on 27/07/2015. The recruitment started on 20/07/2015, after initiation of public registration.