Condition category
Not Applicable
Date applied
07/04/2011
Date assigned
28/04/2011
Last edited
31/08/2012
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

Dr Ingo Beyer

ORCID ID

Contact details

Geriatric Department
UZ Brussel
101 Laarbeeklaan
Brussels
1090
Belgium
+32 (0)2 476 3307
Ingo.Beyer@uzbrussel.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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)

Study design

Single centre double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infection-induced inflammation and related muscle weakness

Intervention

10 mg piroxicam daily versus placebo in addition to standard care including antibiotics

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/05/2005

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/05/2005

Recruitment end date

30/04/2006

Locations

Countries of recruitment

Belgium

Trial participating centre

Geriatric Department
Brussels
1090
Belgium

Sponsor information

Organisation

Brussels University Hospital (Belgium) (Universitair Ziekenhuis Brussel)

Sponsor details

101 Laarbeeklaan
Brussels
1090
Belgium
germst@uzbrussel.be

Sponsor type

Hospital/treatment centre

Website

http://www.uzbrussel.be/

Funders

Funder type

Hospital/treatment centre

Funder name

Brussels University Hospital (Belgium)-Scientific Willy Gepts Fund ("Wetenschappelijk Fonds Willy Gepts" of the Universitair Ziekenhuis Brussel)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Brugmann University Hospital Brussels Centre (Belgium) (Centre Hospitalier Universitaire Brugmann and Universitair Ziekenhuis Brussel, Brussels)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22057579

Publication citations

  1. Results

    Beyer I, Njemini R, Bautmans I, Demanet C, Mets T, Immunomodulatory effect of NSAID in geriatric patients with acute infection: effects of piroxicam on chemokine/cytokine secretion patterns and levels of heat shock proteins. A double-blind randomized controlled trial. (ISRCTN58517443)., Cell Stress Chaperones, 2012, 17, 2, 255-265, doi: 10.1007/s12192-011-0304-4.

Additional files

Editorial Notes