Cyclo-oxygenase inhibition and muscular function in hospitalised geriatric patients with inflammation

ISRCTN	ISRCTN58517443
DOI	https://doi.org/10.1186/ISRCTN58517443
Protocol serial number	N/A
Sponsor	Brussels University Hospital (Belgium) (Universitair Ziekenhuis Brussel)
Funders	Brussels University Hospital (Belgium)-Scientific Willy Gepts Fund ("Wetenschappelijk Fonds Willy Gepts" of the Universitair Ziekenhuis Brussel), Brugmann University Hospital Brussels Centre (Belgium) (Centre Hospitalier Universitaire Brugmann and Universitair Ziekenhuis Brussel, Brussels)

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

Geriatric Department
UZ Brussel
101 Laarbeeklaan
Brussels
1090
Belgium

Phone	+32 (0)2 476 3307
Email	Ingo.Beyer@uzbrussel.be

Study information

Primary study design	Interventional
Study design	Single centre double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	1. Clinical evolution evaluated at discharge 2. Length of stay 3. Tolerance and adverse events evaluated daily throughout hospitalisation
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes