Condition category
Circulatory System
Date applied
24/08/2005
Date assigned
26/08/2005
Last edited
29/11/2007
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 Cornelia Hoedemaekers

ORCID ID

Contact details

Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands
C.Hoedemaekers@ic.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CH0401

Study information

Scientific title

Acronym

CH0401

Study hypothesis

Strict glucose control in critically ill patients alters the cytokine balance towards a more pro-inflammatory state.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Coronary artery bypass graft

Intervention

Strict glucose control (blood glucose between 80-110 mg/dl) versus placebo (blood glucose >200 mg/dl).

Intervention type

Drug

Phase

Not Specified

Drug names

Insulin

Primary outcome measures

Cytokine levels

Secondary outcome measures

Complement concentration

Overall trial start date

01/09/2003

Overall trial end date

01/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults, after uncomplicated CABG
2. Non-diabetics

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Diabetes
2. Renal failure
3. Use of anti-inflammatory drugs
4. Recent myocardial ischemia

Recruitment start date

01/09/2003

Recruitment end date

01/11/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

Radboud University Nijmegen Medical Centre (The Netherlands)

Sponsor details

Geert Groteplein 10
Nijmegen
6500 HB
Netherlands
+31 (0)24 3617273
H.vanderHoeven@ic.umcn.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Department of Intensive Care, Radboud University Nijmegen Medical Centre

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

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16356228

Publication citations

  1. Results

    Hoedemaekers CW, Pickkers P, Netea MG, van Deuren M, Van der Hoeven JG, Intensive insulin therapy does not alter the inflammatory response in patients undergoing coronary artery bypass grafting: a randomized controlled trial [ISRCTN95608630]., Crit Care, 2005, 9, 6, R790-7, doi: 10.1186/cc3911.

Additional files

Editorial Notes