Condition category
Urological and Genital Diseases
Date applied
20/07/2010
Date assigned
14/10/2010
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uhb.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

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