The role of ghrelin in acute versus prolonged critical illness

ISRCTN ISRCTN49433936
DOI https://doi.org/10.1186/ISRCTN49433936
Secondary identifying numbers N/A
Submission date
20/11/2009
Registration date
07/12/2009
Last edited
07/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Greet Van den Berghe
Scientific

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

Email greet.vandenberghe@med.kuleuven.be

Study information

Study designSingle-centre observational study
Primary study designObservational
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe role of ghrelin in acute versus prolonged critical illness: A single centre, observational trial
Study objectivesTo investigate whether (impaired) endogenous ghrelin secretion plays a role in the impaired pulsatile GH secretion and action during prolonged critical illness.
Ethics approval(s)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).
Health condition(s) or problem(s) studiedCritical illness
InterventionThe 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 typeOther
Primary outcome measureConcentrations of ghrelin and GH will be measured in each sample.
Secondary outcome measures1. 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 study start date01/02/2007
Completion date31/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants8 patients and 8 healthy control subjects
Key inclusion criteria1. Patients admitted to any of the five intensive care units (ICUs)
2. Older than 18 years
3. Age, gender and BMI matched healthy subjects
Key exclusion criteria1. 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.
Date of first enrolment01/02/2007
Date of final enrolment31/10/2010

Locations

Countries of recruitment

  • Belgium

Study participating centre

Director of the Department of Intensive Care Medicine
Leuven
3000
Belgium

Sponsor information

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)
University/education

Herestraat 49
Leuven
3000
Belgium

ROR logo "ROR" https://ror.org/05f950310

Funders

Funder type

University/education

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)

No information available

Research Foundation, Flanders (Fond Wetenschappelijk Onderzoek Vlaanderen [FWO]) (Belgium)

No information available

Supported by long term structural funding Methusalem - funding by the Flemish Government

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/04/2013 Yes No