Randomised controlled study of 'physiological' peritoneal dialysis solutions

ISRCTN	ISRCTN37099489
DOI	https://doi.org/10.1186/ISRCTN37099489
Secondary identifying numbers	N0205182207

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 29/03/2018

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 S Fan
Scientific

Department of Renal Medicine and Transplantation
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Phone	+44 0207 377 7367
Email	s.fan@qmul.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Randomised controlled study of 'physiological' peritoneal dialysis solutions
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Peritoneal dialysis
Intervention	"Physiological" (pH neutral) versus "standard" (low pH) dialysate solution
Intervention type	Other
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 study start date	29/01/2004
Completion date	29/04/2013

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	131
Key inclusion criteria	All patients selected to use a PD system that has physiological and standard solutions available
Key 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)
Date of first enrolment	29/01/2004
Date of final enrolment	29/04/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Renal Medicine and Transplantation

London
E1 1BB
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Barts and The London NHS Trust

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

29/03/2018: No publications found, verifying study status with principal investigator
29/01/2016: No publications found, verifying study status with principal investigator