Contact information
Type
Scientific
Primary contact
Prof Greet Van den Berghe
ORCID ID
Contact details
Director of the Department of Intensive Care Medicine
Catholic University Leuven University Hospitals
and
Chair of the Division of Acute Medical Sciences
Catholic University Leuven
Herestraat 49
Leuven
3000
Belgium
greet.vandenberghe@med.kuleuven.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The role of ghrelin in acute versus prolonged critical illness: A single centre, observational trial
Acronym
Study hypothesis
To investigate whether (impaired) endogenous ghrelin secretion plays a role in the impaired pulsatile GH secretion and action during prolonged critical illness.
Ethics approval
Study protocol and consent forms were approved by the Institutional Review Board (IRB) of the Catholic University Leuven School of Medicine on the 10th of November 2006 (ref: ML2112).
Study design
Single-centre observational study
Primary study design
Observational
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Critical illness
Intervention
The patients will be studied once on day 1-2 of ICU admission, and once on day 10-14 (if still in ICU). Blood sampling from patients and healthy volunteers will take place during the night from 21.00 h to 06.00 h every 20 minutes.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Concentrations of ghrelin and GH will be measured in each sample.
Secondary outcome measures
1. Information obtained from each patient at baseline
1.1. Demographic
1.2. Diagnostic
1.3. Therapeutic
1.4. Severity of illness (Acute Physiology and Chronic Health Evaluation [APACHE-II]) (Knaus W.A. et al. Critical Care Medicine, 1985, 13:818-829)
2. Evaluation of trends in organ dysfunction (Sepsis-related Organ Failure Assessment score [SOFA]) (Intensive Care Med. 1996,22:707-10)
3. At 06.00h, serum concentrations of the following will be measured:
3.1. Insulin-like growth factor I (IGF-I)
3.2. IGF-binding protein-1 (IGFBP-1)
3.3. IGFBP-3
3.4. The acid-labile subunit (ALS)
3.5. IGFBP-4
3.6. IGFBP-5
3.7. Insulin
3.8. Leptin
3.9. TSH
3.10. Cortisol
3.11. Adrenocorticotrophic Hormone (ACTH)
Overall trial start date
01/02/2007
Overall trial end date
31/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients admitted to any of the five intensive care units (ICUs)
2. Older than 18 years
3. Age, gender and BMI matched healthy subjects
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
8 patients and 8 healthy control subjects
Participant exclusion criteria
1. Age less than 18 years
2. Pre-existing neurological, psychiatric, metabolic, or endocrine disease
3. Intracranial hypertension
4. Intracranial lesions which could influence the hypothalamus-pituitary axis function
5. Gastrectomy
6. Clinically significant liver failure (prothrombin time <30%)
7. Concomitant treatment with thyroid hormones high dose glucocorticoids (>90mg hydrocortisone/day or >18 mg methyl-prednisolone/day), somatostatin, clonidine, dopamine or dopamine antagonist.
Recruitment start date
01/02/2007
Recruitment end date
31/10/2010
Locations
Countries of recruitment
Belgium
Trial participating centre
Director of the Department of Intensive Care Medicine
Leuven
3000
Belgium
Funders
Funder type
University/education
Funder name
Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research Foundation, Flanders (Fond Wetenschappelijk Onderzoek Vlaanderen [FWO]) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Supported by long term structural funding Methusalem - funding by the Flemish Government
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
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23506003
Publication citations
-
Results
Boonen E, Vervenne H, Meersseman P, Andrew R, Mortier L, Declercq PE, Vanwijngaerden YM, Spriet I, Wouters PJ, Vander Perre S, Langouche L, Vanhorebeek I, Walker BR, Van den Berghe G, Reduced cortisol metabolism during critical illness., N. Engl. J. Med., 2013, 368, 16, 1477-1488, doi: 10.1056/NEJMoa1214969.