Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
02/08/2010
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 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

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

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

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

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)

Publication citations

Additional files

Editorial Notes