Cyclo-oxygenase inhibition and muscular function in hospitalised geriatric patients with inflammation
| ISRCTN | ISRCTN58517443 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58517443 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/04/2011
- Registration date
- 28/04/2011
- Last edited
- 31/08/2012
- 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
Dr Ingo Beyer
Scientific
Scientific
Geriatric Department
UZ Brussel
101 Laarbeeklaan
Brussels
1090
Belgium
| Phone | +32 (0)2 476 3307 |
|---|---|
| Ingo.Beyer@uzbrussel.be |
Study information
| Study design | Single centre double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | NSAID treatment with piroxicam versus placebo in hospitalised geriatric patients with infection-induced inflammation - influence on muscle function: a single centre double blind randomised controlled trial |
| Study objectives | The treatment with a non steroidal anti-inflammatory drug (NSAID) in addition to standard antibiotic therapy might attenuate infection-induced inflammation and reduce its negative effects on muscle function |
| Ethics approval(s) | Hospital ethics committee (Comité d'éthique hospitalier), CHU Brugmann approved on 17/12/2004 and amendements approved on 19/05/2005 (N/Ref CE 2004/44) |
| Health condition(s) or problem(s) studied | Infection-induced inflammation and related muscle weakness |
| Intervention | 10 mg piroxicam daily versus placebo in addition to standard care including antibiotics |
| Intervention type | Other |
| Primary outcome measure | 1. Skeletal muscle mass (total body potassium) evaluated at baseline & weekly thereafter maximum two times 2. Muscle performance (grip strength, fatigue resistance and Elderly Mobility Scale (EMS) score evaluated at baseline & weekly thereafter with a maximum of three weeks 3. Inflammation (levels of cytokines and heat shock proteins) evaluated at baseline, daily during the first 3 days and weekly after baseline with a maximum of three weeks |
| Secondary outcome measures | 1. Clinical evolution evaluated at discharge 2. Length of stay 3. Tolerance and adverse events evaluated daily throughout hospitalisation |
| Overall study start date | 01/05/2005 |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Patients hospitalised in an acute geriatric ward 2. Age > 70 years 3. Inflammation, not due to surgery or burns, and documented by an increase of serum concentration of C-reactive protein (CRP) (> 10 mg/L) and/or fibrinogen (>400 mg/dL) 4. Informed consent |
| Key exclusion criteria | 1. General condition, dementia or confusion, not allowing the testing 2. Patients in (pre) terminal phase 3. Use of corticosteroids or non -steroidal anti-inflammatory drugs (NSAIDs) in the past 7 days; the use of inhalation corticosteroids, of low dose aspirin (as anti-aggregating medication) or of paracetamol is allowed 4. Contra-indication for the use of cyclo-oxygenase (COX)-2 inhibitors |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Geriatric Department
Brussels
1090
Belgium
1090
Belgium
Sponsor information
Brussels University Hospital (Belgium) (Universitair Ziekenhuis Brussel)
Hospital/treatment centre
Hospital/treatment centre
101 Laarbeeklaan
Brussels
1090
Belgium
| germst@uzbrussel.be | |
| Website | http://www.uzbrussel.be/ |
"ROR" |
https://ror.org/038f7y939 |
Funders
Funder type
Hospital/treatment centre
Brussels University Hospital (Belgium)-Scientific Willy Gepts Fund ("Wetenschappelijk Fonds Willy Gepts" of the Universitair Ziekenhuis Brussel)
No information available
Brugmann University Hospital Brussels Centre (Belgium) (Centre Hospitalier Universitaire Brugmann and Universitair Ziekenhuis Brussel, Brussels)
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 | 01/03/2012 | Yes | No |
