Contact information
Type
Scientific
Primary contact
Dr Mark Wright
ORCID ID
Contact details
Renal and Liver Services
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2933
mark.wright@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436151094
Study information
Scientific title
A randomised crossover study to determine the effect of glucose enriched dialysis fluid on post-dialysis cognitive function
Acronym
Study hypothesis
We 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
Not provided at time of registration
Study design
Randomised controlled crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Nervous System Diseases: Cognition disorders
Intervention
Interviews; Before-after trial
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Mini mental state exam score
2. Clock face drawing test score
Secondary outcome measures
Not provided at time of registration
Overall trial start date
14/06/2004
Overall trial end date
14/08/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing haemodialysis on ward 50 at the LGI
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. 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
Recruitment start date
14/06/2004
Recruitment end date
14/08/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds General Infirmary
Renal and Liver Services
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
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
Leeds Teaching Hospitals NHS Trust (UK) - 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
2006 conference proceedings in http://ndt.oxfordjournals.org/cgi/reprint/21/suppl_4/iv170 (iv175, SP476)