Condition category
Musculoskeletal Diseases
Date applied
20/09/2011
Date assigned
09/11/2011
Last edited
30/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recently, studies have shown that elderly patients tend to suffer more from muscle weakness and muscle fatigue post-surgery than compared to younger patients. Also, we found evidence that muscle fatigue caused by inflammation is due to local processes (such as muscle atrophy and loss of contractibility), acting at the muscle itself. The aim of this study is to evaluate how different treatments work to reduce postoperative muscle weakness and muscle fatigue in elderly elective abdominal surgery patients.

Who can participate?
All elderly (male or female, aged >60 years) elective abdominal surgery patients are eligible.

What does the study involve?
Participants will be randomly allocated to either one of three drugs (including a drug which is a tumour necrosis factor-alpha (TNF-a) inhibitor) or a dummy drug (placebo), before during and after surgery.

What are the possible benefits and risks of participating?
We expect that the treatment will reduce the postoperative muscle weakness and fatigue.
Patients will be excluded when contra-indications for the use of the study-medication exists. A recent study showed that TNF-a treatment did not increase the risk for surgical site infection.

Where is the study run from?
The leading centre is the Frailty in Aging research group of the Vrije Universiteit Brussel, in collaboration with the Universitair Ziekenhuis Brussel (University Hospital of the Vrije Universiteit Brussel), Belgium

When is the study starting and how long is it expected to run for?
October 2011 to September 2013.

Who is funding the study?
Frailty in Ageing research group of the Vrije Universiteit Brussel, in collaboration with the Universitair Ziekenhuis Brussel (University Hospital of the Vrije Universiteit Brussel), Belgium

Who is the main contact?
Dr Ivan Bautmans
ivan.bautmans@vub.ac.be

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ivan Bautmans

ORCID ID

Contact details

Laarbeeklaan 103
Brussels
1090
Belgium
ivan.bautmans@vub.ac.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of peri-operative anti-inflammatory treatment on postoperative muscle weakness and muscle fatigue in elderly elective surgery patients: a double blinded randomized placebo-controlled trial

Acronym

Study hypothesis

Could Pharmacological interventions designed to prevent inflammation-induced structural changes in the skeletal muscle reduce postoperative muscle weakness and muscle fatigue in elderly elective abdominal surgery patients?

Ethics approval

Brussels University Hospital Medical Ethical Committee (Universitair Ziekenhuis Brussel)

Study design

Double blinded randomised placebo-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

Post-operative muscle weakness, fatigue and inflammation

Intervention

Three different pharmacological interventions, each counter-acting different steps of the inflammation-induced proteolytic pathway in skeletal muscle, will be compared to placebo control:
1. Tumor necrosis factor-alpha (TNF-a) inhibitor [50mg Etanercept by subcutaneous (SC) injection 1 day preoperative, N=25)
2. Calpain inhibitor (16mg Molsidomine daily by mouth (per os), starting 1 day preoperative until 1 week postoperative, N=25)
3. Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-eB) downregulator (267mg Fenofibrate daily, starting 1 day preoperative until 1 week postoperative N=25)
4. Placebo control (N=25)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Muscle performance: Maximal handgrip strength, muscle fatigue resistance and grip work will be assessed one day before surgery, and 2, 4, 8 and 30 days post-surgery
2. Self-perceived fatigue and pain: self-perceived fatigue (Fatigue subscale of the Profile of Mood State) and pain (Visual Analogue Scale) will be assessed one day before surgery, and 2, 4, 8 and 30 days post-surgery
3. Inflammation: circulating levels of pro- and anti-inflammatory cytokines and their intra-cellular gene expression in Peripheral Mononuclear Blood Cells. Overnight fasting serum samples will be collected from the non-dominant arm at one day before surgery, and 2, 4, 8 and 30 days post-surgery.

Secondary outcome measures

Occurrence of adverse reactions and postoperative complications:
All participants will be questioned and monitored for adverse reactions (potentially related to the study medication, i.e. allergies, headache, hypotension) at day 2, 4, 8 and 30 post-surgery.

Occurrence of postoperative complications will be extracted from the patient’s medical record.

Overall trial start date

01/10/2011

Overall trial end date

01/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All elderly (male or female, aged > 60 years) elective abdominal surgery patients

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

N=100 (N=25 per treatment arm)

Participant exclusion criteria

1. Unavailable one day before the surgical intervention
2. Presenting important inflammation preoperatively C-reactive protein (CRP)>10mg/L
3. Unable to understand or execute the test instructions due to cognitive impairment mini mental state examination (MMSE<23 / 30) and/or physical disability
4. Already using selective tumor necrosis factor (TNF)-alpha inhibitors, nitric oxide donors, fibrates, non-steroidal anti-inflammatory drugs (NSAID’s) or corticosteroids or when contra-indications for the use of one of these products exist

Recruitment start date

01/10/2011

Recruitment end date

01/10/2013

Locations

Countries of recruitment

Belgium

Trial participating centre

Laarbeeklaan 103
Brussels
1090
Belgium

Sponsor information

Organisation

Vrije University Brussels [Vrije Universiteit Brussel] (Belgium)

Sponsor details

Frailty in Ageing Research Department
Laarbeeklaan 103
Brussels
1090
Belgium
ivan.bautmans@vub.ac.be

Sponsor type

University/education

Website

http://www.vub.ac.be/FRIA

Funders

Funder type

University/education

Funder name

University of Brussels (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Brussels University Hospital (Belgium)

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

http://www.ncbi.nlm.nih.gov/pubmed/19808837

Publication citations

  1. Bautmans I, Njemini R, De Backer J, De Waele E, Mets T, Surgery-induced inflammation in relation to age, muscle endurance, and self-perceived fatigue., J. Gerontol. A Biol. Sci. Med. Sci., 2010, 65, 3, 266-273, doi: 10.1093/gerona/glp145.

Additional files

Editorial Notes