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 |
| Protocol serial number | 1.0 |
| Sponsor | University Hospitals Birmingham NHS Foundation Trust (UK) |
| Funder | Gambro AB (Sweden) - Disposables are provided free of charge |
- Submission date
- 20/07/2010
- Registration date
- 14/10/2010
- Last edited
- 19/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Contact information
Dr Paul Cockwell
Scientific
Scientific
University Hospital Birmingham
Metchley lane
Birmingham
B152TH
United Kingdom
| paul.cockwell@uhb.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active-controlled crossover group trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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(s) |
Safety as defined by the maintenance of serum albumin. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospital Birmingham
Birmingham
B152TH
United Kingdom
B152TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/09/2016: No publications found, verifying study status with principal investigator.
