Safety and efficacy study of high cut-off haemodialysis as a maintenance therapy for end stage renal failure

ISRCTN	ISRCTN06015076
DOI	https://doi.org/10.1186/ISRCTN06015076
Secondary identifying numbers	1.0

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Paul Cockwell
Scientific

University Hospital Birmingham
Metchley lane
Birmingham
B152TH
United Kingdom

Email	paul.cockwell@uhb.nhs.uk

Study design	Randomised active-controlled crossover group trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Safety and efficacy study of high cut-off haemodialysis as a maintenance therapy for end stage renal failure: a randomised crossover trial
Study objectives	The increased removal of middle molecules and protein bound toxins by high cut-off haemodialysis will reduce inflammation in chronic dialysis patients.
Ethics approval(s)	Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2, ref: 10/H0402/31
Health condition(s) or problem(s) studied	End stage renal failure, haemodialysis
Intervention	High cut-off dialysis
Intervention type	Other
Primary outcome measure	Safety as defined by the maintenance of serum albumin.
Secondary outcome measures	1. Kinetics of removal of uraemic toxins (middle molecules and protein bound toxins) and the corresponding sustained reductions seen with the different dialysis schedules evaluated. 2. Dialysis dose 3. Quality of life 4. Thrombosis 5. Pulse wave velocity
Overall study start date	25/07/2010
Completion date	31/01/2011

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	45
Key inclusion criteria	1. Functioning AV-fistula 2. Between the ages of 18 and 80 years 3. End Stage Renal Failure (ESRF) undergoing regular haemodialysis (for > 3 months)
Key exclusion criteria	1. Terminal illness 2. Dialysis catheter in-situ 3. History of recurrent/poorly controlled infections 4. Inflammatory disease 5. Immunosuppressants 6. Cardiac or respiratory failure
Date of first enrolment	25/07/2010
Date of final enrolment	31/01/2011

University Hospital Birmingham

Birmingham
B152TH
United Kingdom

University Hospitals Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre

Metchley Lane
Birmingham
B152TH
England
United Kingdom

Industry

Gambro AB (Sweden) - Disposables are provided free of charge

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

19/09/2016: No publications found, verifying study status with principal investigator.