An investigation into whether tight glucose control improves mortality in patients admitted to combined Intensive Therapy Unit/High Dependency Unit (ITU/HDU)

ISRCTN ISRCTN31624090
DOI https://doi.org/10.1186/ISRCTN31624090
Secondary identifying numbers N0247130746
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
05/12/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Malcolm Watters
Scientific

The Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAn investigation into whether tight glucose control improves mortality in patients admitted to combined Intensive Therapy Unit/High Dependency Unit (ITU/HDU)
Study objectivesDoes intensive glucose control improve outcome in a population of Intensive Therapy Unit/High Dependency Unit (ITU/HDU) patients?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNot Applicable
InterventionGroup 1: Intensive insulin therapy - the blood glucose will be maintained between 4.4 and 6.1 mmol/L using intravenous insulin therapy
Group 2: Conventional insulin therapy - the blood glucose will be maintained between 10.0 and 11.1 mmol/L using intravenous insulin therapy
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Insulin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date10/03/2003
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaITU/HDU patients
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/03/2003
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Great Western Hospital
Swindon
SN3 6BB
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Swindon and Marlborough NHS Trust (UK)

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