A randomised crossover study to determine the effect of glucose enriched dialysis fluid on post-dialysis cognitive function

ISRCTN ISRCTN47648806
DOI https://doi.org/10.1186/ISRCTN47648806
Secondary identifying numbers N0436151094
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
14/09/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Wright
Scientific

Renal and Liver Services
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone +44 (0)113 392 2933
Email mark.wright@leedsth.nhs.uk

Study information

Study designRandomised controlled crossover group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised crossover study to determine the effect of glucose enriched dialysis fluid on post-dialysis cognitive function
Study objectivesWe intend to use two simple tests before and after a haemodialysis (HD) session to see how commonly HD induces a degree of delirium. After our initial survey, we shall repeat the tests after introducing glucose enriched dialysis fluid to see if this reduces the number of people that have a deterioration of their score
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNervous System Diseases: Cognition disorders
InterventionInterviews; Before-after trial
Intervention typeOther
Primary outcome measure1. Mini mental state exam score
2. Clock face drawing test score
Secondary outcome measuresNot provided at time of registration
Overall study start date14/06/2004
Completion date14/08/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients undergoing haemodialysis on ward 50 at the LGI
Key exclusion criteria1. Not being able to understand the questions of the mini-mental state of examination or the instructions for the clock drawing
2. Having visual impairment or physical disability that prevents accurate clock drawing
Date of first enrolment14/06/2004
Date of final enrolment14/08/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leeds General Infirmary
Renal and Liver Services
Leeds
LS1 3EX
United Kingdom

Sponsor information

Department of Health
Government

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

Leeds Teaching Hospitals NHS Trust (UK) - NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results conference proceedings 01/07/2006 No No

Editorial Notes

14/09/2017: internal review.