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
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
| greet.vandenberghe@med.kuleuven.be |
Study information
| Study design | Single-centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The role of ghrelin in acute versus prolonged critical illness: A single centre, observational trial |
| Study objectives | To 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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2007 |
| Completion date | 31/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8 patients and 8 healthy control subjects |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 31/10/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Director of the Department of Intensive Care Medicine
Leuven
3000
Belgium
3000
Belgium
Sponsor information
Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)
University/education
University/education
Herestraat 49
Leuven
3000
Belgium
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
