Condition category
Urological and Genital Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
29/01/2016
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 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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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