Investigation of the protective effects of keratinocyte growth factor (KGF) in a human lipopolysaccharide induced model of acute lung injury
| ISRCTN | ISRCTN98813895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98813895 |
| EudraCT/CTIS number | 2008-000441-58 |
| Secondary identifying numbers | MRC ref: G0701690; 08005DM-A |
- Submission date
- 25/04/2008
- Registration date
- 12/12/2008
- Last edited
- 19/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=20564&q=0%c2%ac08%2fNIR02%2f46%c2%ac
Contact information
Dr Danny McAuley
Scientific
Scientific
Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
| Study design | Prospective randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Does treatment with a clinically relevant dose of keratinocyte growth factor (KGF) reduce pulmonary and systemic inflammation induced by lipopolysaccharide (LPS) inhalation in humans? |
| Ethics approval(s) | Health and Social Care (HSC) Research Ethics Committee (REC2), Department of Health, Social Services and Public Safety (DHSSPS), approved on 21/07/2008 (ref: 08/NIR02/46) |
| Health condition(s) or problem(s) studied | Acute lung injury (ALI) |
| Intervention | Subjects will be randomised to palifermin 60 µg/kg per day or normal saline placebo intravenously for 3 days prior to LPS inhalation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Keratinocyte growth factor (KGF) |
| Primary outcome measure | The ability of KGF to reduce alveolar inflammation, as measured by the difference in bronchoalveolar lavage (BAL) receptor for advanced glycation end products (RAGE) concentration between the KGF and placebo treated groups at 6 hours post LPS inhalation. |
| Secondary outcome measures | 1. Alveolar inflammatory response at 6 hours post LPS inhalation 2. Plasma inflammatory response (C-reactive protein) at 24 hours post LPS inhalation 3. Alveolar matrix metalloproteinase activity at 6 hours post LPS inhalation 4. Intracellular signalling in the alveolar space at 6 hours post LPS inhalation 5. Indices of alveolar epithelial and endothelial function and injury at 6 hours post LPS inhalation |
| Overall study start date | 01/08/2008 |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Key inclusion criteria | Healthy subjects, both males and females |
| Key exclusion criteria | 1. Age <18 years 2. Pregnancy, breast-feeding or women of childbearing potential not using adequate contraception 3. Serum amylase above upper limit of normal 4. Consent declined |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 01/08/2011 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Intensive Care Unit
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
51 Lisburn Road
Belfast
BT9 7AB
Northern Ireland
United Kingdom
| Phone | +44 289 03 29241 |
|---|---|
| rosemary.mcveigh@belfasttrust.hscni.net | |
| Website | http://www.belfasttrust.hscni.net |
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Medical Research Council (UK) (ref: G0701690)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
REVIVE (a charity which supports research in the intensive care unit in the Royal Victoria Hospital, Belfast) (UK)
No information available
Northern Ireland Chest Heart and Stroke (NICHS) (UK)
No information available
Added as of 30/12/2008:
No information available
Research and Development Office, Northern Ireland Health and Social Services, Central Services Agency (UK)
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 | 15/06/2014 | Yes | No |
