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
-
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.