Contact information
Type
Scientific
Primary contact
Dr Paul Cockwell
ORCID ID
Contact details
University Hospital Birmingham
Metchley lane
Birmingham
B152TH
United Kingdom
-
paul.cockwell@uhb.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
Safety and efficacy study of high cut-off haemodialysis as a maintenance therapy for end stage renal failure: a randomised crossover trial
Acronym
Study hypothesis
The increased removal of middle molecules and protein bound toxins by high cut-off haemodialysis will reduce inflammation in chronic dialysis patients.
Ethics approval
Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2, ref: 10/H0402/31
Study design
Randomised active-controlled crossover group trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
End stage renal failure, haemodialysis
Intervention
High cut-off dialysis
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
25/07/2010
Overall trial end date
31/01/2011
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant 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
Recruitment start date
25/07/2010
Recruitment end date
31/01/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Birmingham
Birmingham
B152TH
United Kingdom
Sponsor information
Organisation
University Hospitals Birmingham NHS Foundation Trust (UK)
Sponsor details
Metchley Lane
Birmingham
B152TH
United Kingdom
-
chirs.counsell@uhb.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Gambro AB (Sweden) - Disposables are provided free of charge
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary