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The role of ghrelin in acute versus prolonged critical illness
ISRCTN ISRCTN49433936
DOI 10.1186/ISRCTN49433936
ClinicalTrials.gov identifier
EudraCT number
Public title The role of ghrelin in acute versus prolonged critical illness
Scientific title The role of ghrelin in acute versus prolonged critical illness: A single centre, observational trial
Acronym N/A
Serial number at source N/A
Study hypothesis To investigate whether (impaired) endogenous ghrelin secretion plays a role in the impaired pulsatile GH secretion and action during prolonged critical illness.
Lay summary Not provided at time of registration
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
Countries of recruitment Belgium
Disease/condition/study domain Critical illness
Participants - 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
Participants - 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.
Anticipated start date 01/02/2007
Anticipated end date 31/10/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 8 patients and 8 healthy control subjects
Interventions 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.
Primary outcome measure(s) Concentrations of ghrelin and GH will be measured in each sample.
Secondary outcome measure(s) 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)
Sources of funding 1. Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)
2. Research Foundation, Flanders (Fond Wetenschappelijk Onderzoek Vlaanderen [FWO]) (Belgium)
3. Supported by long term structural funding Methusalem - funding by the Flemish Government
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23506003
Contact name Prof  Greet  Van den Berghe
  Address 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
  City/town Leuven
  Zip/Postcode 3000
  Country Belgium
  Email greet.vandenberghe@med.kuleuven.be
Sponsor Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)
  Address Herestraat 49
  City/town Leuven
  Zip/Postcode 3000
  Country Belgium
Date applied 20/11/2009
Last edited 07/05/2013
Date ISRCTN assigned 07/12/2009
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