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
Protocol serial number	N0436151094
Sponsor	Department of Health
Funder	Leeds Teaching Hospitals NHS Trust (UK) - NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled crossover group trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised crossover study to determine the effect of glucose enriched dialysis fluid on post-dialysis cognitive function
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nervous System Diseases: Cognition disorders
Intervention	Interviews; Before-after trial
Intervention type	Other
Primary outcome measure(s)	1. Mini mental state exam score 2. Clock face drawing test score
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	14/08/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Patients undergoing haemodialysis on ward 50 at the LGI
Key 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
Date of first enrolment	14/06/2004
Date of final enrolment	14/08/2004

Leeds General Infirmary

Renal and Liver Services
Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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

14/09/2017: internal review.