| Source of record | UK Trials |
| ISRCTN | ISRCTN37099489 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0205182207 |
| Public title | Randomised controlled study of 'physiological' peritoneal dialysis solutions |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Urological and Genital Diseases: Peritoneal dialysis |
| Study hypothesis | We propose conducting a randomised controlled study of new patients commencing peritoneal dialysis. We shall compare patients who start on 'physiological' (bicarbonate-based) versus 'standard' (lactacte-based) dialysate solution. We propose to study the effect of these solutions on mortality, duration of successful PD and peritonitis rates. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All patients selected to use a PD system that has physiological and standard solutions available |
| Participants - exclusion criteria | 1. Patients unable to provide informed consent
2. Patients where the use of a certain solution is indicated or contra-indicated for medical reasons (eg known allergy) |
| Patient information material |
|
| Anticipated start date | 29/01/2004 |
| Anticipated end date | 29/04/2013 |
| Status of trial | Ongoing |
| Target number of participants | 131 |
| Interventions | "Physiological" (pH neutral) versus "standard" (low pH) dialysate solution |
| Primary outcome measure(s) | Patients using physiological solutions will have lower peritonitis rate than control group. |
| Secondary outcome measure(s) | 1. Patients using physiological solutions will have better preservation of residual kidney function
2. Patients using physiological solutions will have smaller changes in peritoneal membrane function assessed by PET than control group
3. Patients using physiological solutions will have reduced composite end-point of mortality and PD failure defined by transfer to HD in patients using physiological solutions |
| Sources of funding | Barts and The London NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr S Fan |
| Contact details | Department of Renal Medicine and Transplantation
The Royal London Hospital
Whitechapel
London
United Kingdom
E1 1BB |
| Contact telephone | +44 0207 377 7367 |
| Contact fax | +44 0207 377 7003 |
| Contact email | s.fan@qmul.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN37099489 |
| Date last extracted from ISRCTN register | 17/04/2008 |
