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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02042768
Other study ID # RG-0077-16, 010/12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2013
Est. completion date December 31, 2020

Study information

Verified date January 2022
Source Keele University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Peritoneal Dialysis (PD) is a commonly used treatment for end stage renal failure, and the most commonly used dialysate contains unphysiological amounts of glucose, a high proportion of which is absorbed. Recent analysis of the Global Fluid Study, has established that in non-diabetic prevalent patients on PD a random glucose level is dependent on dialysate glucose load and is a predictor of death. By utilising clinical data and additional biosamples collected for the NIHR funded PD-CRAFT study, the investigators aim to confirm this finding, define the relationship between dialysate glucose exposure according to prescription regimes and glycaemia, define the most useful biomarker to monitor glycaemia , and establish the role that impaired insulin sensitivity plays in blood glucose levels. Furthermore the investigators will explore the hypothesis that insulin resistance is associated with disturbance of the carnitine/acetyl-carnitine equilibrium that might benefit from intra-peritoneal carnitine supplementation. PD-CRAFT is an observational cohort study of 3000 prevalent PD patients collecting detailed clinical data, including glucose exposure and samples of dialysate. and blood which will be stored in the UK BioCentre. Follow up is for up to 2 years or endpoint (death, technique failure). Multivariate regression will be used to establish determinants of the non-fasting blood glucose and other measures of glycaemia, in particular different dialysis regimes, (e.g. modality, dwell lengths, fill volumes, and dialysate type and concentration specifically seeking to identify prescriptions that minimise the systemic effects) combined with measures of insulin resistance. The investigators will establish whether blood glucose predicts survival in an adjusted analysis (~300 endpoints needed) using Cox regression and explore the relationship of other biomarkers to survival.


Recruitment information / eligibility

Status Completed
Enrollment 1451
Est. completion date December 31, 2020
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - On peritoneal dialysis Exclusion Criteria: - Not providing informed consent. - Diabetes.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom University Hospital of North Staffordshire Stoke-on-Trent North Staffordshire

Sponsors (4)

Lead Sponsor Collaborator
Keele University Baxter Healthcare Corporation, Kidney Cancer UK, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality From study entry to date of death from any cause, assessed up to June 2015 Patients will be followed up for the duration of the study period, an expected average of 24 months
Secondary Cardiovascular mortality From study entry up to date of death from cardiovascular cause, assessed up to June 2015 Patients will be followed up for the duration of the study period, an expected average of 24 months
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