Inflammatory ResponsePhase 4CORTERASNCT05220319
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
A Phase 4 study testing Methylprednisolone and NaCl 0.9% in people with Inflammatory Response and Weakness, Muscle, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Inflammatory Response, Weakness, Muscle
- What is being tested?
- Methylprednisolone and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 751 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2022to 28 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years or older.
- Scheduled for one of the predefined surgical procedures:
- off-pump coronary bypass surgery
- on-pump coronary bypass surgery
- aortic and mitral valve replacement
- laparoscopic hemicolectomies
Show all 9Show fewer
- thoracoscopic lung resections
- femoral popliteal and tibial bypass surgery and femoral profundoplasty
- laparoscopic radical prostatectomies
Who cannot join
- Lack of informed consent or inability to give informed consent.
- Severe postoperative nausea \& vomiting (PONV), needing corticosteroids as PONV prophylaxis.
- Urgent, not elective surgery
- Hypersensitivity or known allergic reactions to methylprednisolone
- Preoperative systemic use of steroids:
- Including, but not limited to, the use of corticosteroids > 4 weeks before surgery of at least 4 mg methylprednisolone equivalents.
- Excluding inhalational and topical steroids
- Preexisting muscle disease o Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.
Trial locations and contacts
1 site in 1 country.
About this study
Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery.
Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome.
The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.
Read the detailed description
The number of elderly patients undergoing surgery is expected to increase in the coming years, due to the increase in life expectancy in the developing world. Compared to younger surgical patients, the older patients are at greater risk of mortality and morbidity after surgery.
Post-operative fatigue is an important complication after surgery. Not only is it reported by patients as one of the most distressing symptoms, it is also thought to be a significant contributor to delayed recovery after surgery. From a pathophysiological point of view, muscle weakness could be a major contributor to this post-operative fatigue.
Recent studies showed a profound reduction in muscle strength after surgery in elderly patients, which lasted for more than 3 months after surgery. This decrease in muscle strength might be induced by an excessive inflammatory response to surgery.
Glucocorticosteroids are capable of tampering an excessive inflammatory response to surgery and could improve the quality of recovery after surgery. However, a possible effect on post-operative muscle weakness hasn't been specifically investigated.
Therefore, the main objective of this prospective clinical trial is to evaluate the effect of corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing surgery.
- Conditions
- Inflammatory Response, Weakness, Muscle
- Being tested
- Methylprednisolone, NaCl 0.9%
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 mg Methylprednisolone made up with 100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional dose in 100 ml will be given.
NaCl 0.9%Drug
100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional 100ml will be given.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 100 ml of NaCl 0,9%, not containing corticosteroids, given at induction of anaesthesia, before surgery.
If a patient will receive cardiopulmonary bypass (CPB) during his operation, a repeat dose of 100 ml of NaCl 0,9% will be administered at the beginning of CPB. Receives: Drug: NaCl 0.9% |
| Methylprednisolone | Active comparator | 250 mg of methylprednisolone made up with 100 ml NaCl 0,9%, given at the induction of anaesthesia, before surgery.
If a patient will receive cardiopulmonary bypass (CPB) during his operation, a repeat dose of 250 mg methylprednisolone will be administered at the beginning of CPB. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative muscle weakness
decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 1 following surgery as compared to the preoperative value
Measured: Pre-operative and Post operative day 1
Secondary outcomes (10)
Post operative muscle weakness
Decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 3 and 5 following surgery as compared to the preoperative value, if still in the hospital.
Measured: Pre-operative and Post operative day 1, 3 and 5
Maximum inspiratory pressure as measure of respiratory muscle function
Maximum inspiratory pressure on day 1, 3 and 5, as compared to pre-operative value, if still in the hospital.
Measured: Pre-operative and Post operative day 1, 3 and 5
Post operative fatigue
Assessed by the Chalder fatigue Questionnaire - 11 items, scores min 0 - max 33, higher score means worse outcome: post-operative day 1, 3, 5 and 28, as compared to preoperatively
Measured: Pre-operative and Post operative day 1, 3, 5 and 28
Quality of recovery (QOR)
Assessed by the QOR-15 scale, scores min 0 - max 150, higher score means worse outcome, assessed on day 1, 3 and 5 as compared to preoperatively
Measured: Post operative day 1, 3 and 5
Functioning at day 28
EuroQol five dimensions of health (EQ5D), score of 1-5 on each health dimension, higher score means worse outcome + visual analogue scale from 0-100 questionning todays health, lower score means worse outcome. EQ5D is assessed on day 28, as compared to pre-operatively values
Measured: Pre-operative and Post operative day 28
Coagulation disorder
biochemical markers of coagulation postoperatively as compared to preoperatively
Measured: postoperatively first 24 hours
Sleeping pattern
Assessed by the Consensus Sleep Diary (CSD) in a subset of study population
Measured: 10 consecutive nights, starting 3 days before surgery
Sleep quality
Assessed by the Pittsburgh Sleep Quality Index (PSQI) in a subet of study population, score range between 0 and 21, higher scores indicate worse sleep quality
Measured: 3 days before and 10 days after surgery
Sleep chronotype
Assessed by the Munich Chronotype Questionnaire (MCTQ) is a subset of study population
Measured: 3 days before surgery
Sleeping EEG pattern
Assessed by EEG recording in a subset of study population
Measured: first postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start16 Feb 2022
- Primary completion30 Sep 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Thiessen, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220319
- Sponsor's protocol ID
- Z-2021070
- Acronym
- CORTERAS
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
- ClinicalTrials.gov ID
- NCT05220319
- Acronym / sponsor ID
- CORTERAS / Z-2021070
- Conditions
- Inflammatory Response, Weakness, Muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery.
Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome.
The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.
Detailed description
The number of elderly patients undergoing surgery is expected to increase in the coming years, due to the increase in life expectancy in the developing world. Compared to younger surgical patients, the older patients are at greater risk of mortality and morbidity after surgery.
Post-operative fatigue is an important complication after surgery. Not only is it reported by patients as one of the most distressing symptoms, it is also thought to be a significant contributor to delayed recovery after surgery. From a pathophysiological point of view, muscle weakness could be a major contributor to this post-operative fatigue.
Recent studies showed a profound reduction in muscle strength after surgery in elderly patients, which lasted for more than 3 months after surgery. This decrease in muscle strength might be induced by an excessive inflammatory response to surgery.
Glucocorticosteroids are capable of tampering an excessive inflammatory response to surgery and could improve the quality of recovery after surgery. However, a possible effect on post-operative muscle weakness hasn't been specifically investigated.
Therefore, the main objective of this prospective clinical trial is to evaluate the effect of corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: NaCl 0.9%100 ml of NaCl 0,9%, not containing corticosteroids, given at induction of anaesthesia, before surgery. If a patient will receive cardiopulmonary bypass (CPB) during his operation, a repeat dose of 100 ml of NaCl 0,9% will be administered at the beginning of CPB. |
| Methylprednisolone | Active comparator | Drug: Methylprednisolone250 mg of methylprednisolone made up with 100 ml NaCl 0,9%, given at the induction of anaesthesia, before surgery. If a patient will receive cardiopulmonary bypass (CPB) during his operation, a repeat dose of 250 mg methylprednisolone will be administered at the beginning of CPB. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 60 years or older.
- Scheduled for one of the predefined surgical procedures:
Key exclusion criteria (8 listed)
- Lack of informed consent or inability to give informed consent.
- Severe postoperative nausea \& vomiting (PONV), needing corticosteroids as PONV prophylaxis.
- Urgent, not elective surgery
- Hypersensitivity or known allergic reactions to methylprednisolone
- Preoperative systemic use of steroids:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone250 mg Methylprednisolone made up with 100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional dose in 100 ml will be given. | Drug | Methylprednisolone |
| NaCl 0.9%100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional 100ml will be given. | Drug | Placebo |
Primary outcome
Post operative muscle weakness
Time frame: Pre-operative and Post operative day 1
decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 1 following surgery as compared to the preoperative value
10 secondary outcomes
Post operative muscle weakness
Time frame: Pre-operative and Post operative day 1, 3 and 5
Maximum inspiratory pressure as measure of respiratory muscle function
Time frame: Pre-operative and Post operative day 1, 3 and 5
Post operative fatigue
Time frame: Pre-operative and Post operative day 1, 3, 5 and 28
Quality of recovery (QOR)
Time frame: Post operative day 1, 3 and 5
Functioning at day 28
Time frame: Pre-operative and Post operative day 28
Coagulation disorder
Time frame: postoperatively first 24 hours
Sleeping pattern
Time frame: 10 consecutive nights, starting 3 days before surgery
Sleep quality
Time frame: 3 days before and 10 days after surgery
Sleep chronotype
Time frame: 3 days before surgery
Sleeping EEG pattern
Time frame: first postoperative night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone and NaCl 0.9% in people with Inflammatory Response and Weakness, Muscle, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative muscle weakness (time frame: Pre-operative and Post operative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.