Contact information
Type
Scientific
Primary contact
Dr S Fan
ORCID ID
Contact details
Department of Renal Medicine and Transplantation
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 0207 377 7367
s.fan@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205182207
Study information
Scientific title
Randomised controlled study of 'physiological' peritoneal dialysis solutions
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Urological and Genital Diseases: Peritoneal dialysis
Intervention
"Physiological" (pH neutral) versus "standard" (low pH) dialysate solution
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Patients using physiological solutions will have lower peritonitis rate than control group.
Secondary outcome measures
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
Overall trial start date
29/01/2004
Overall trial end date
29/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients selected to use a PD system that has physiological and standard solutions available
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
131
Participant 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)
Recruitment start date
29/01/2004
Recruitment end date
29/04/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Renal Medicine and Transplantation
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
Basic results (scientific)
Publication list