Condition category
Not Applicable
Date applied
20/11/2009
Date assigned
07/12/2009
Last edited
07/05/2013
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

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

Sponsor information

Organisation

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)

Sponsor details

Herestraat 49
Leuven
3000
Belgium

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes