Clinical trial NCT05220319: CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
Official title: CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Inflammatory Response
Weakness, Muscle
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 672
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
  * thoracoscopic lung resections
  * femoral popliteal and tibial bypass surgery and femoral profundoplasty
  * laparoscopic radical prostatectomies

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Post operative muscle weakness
timeFrame: Pre-operative and Post operative day 1
Secondary outcomes:
measure: Post operative muscle weakness
timeFrame: Pre-operative and Post operative day 1, 3 and 5
measure: Maximum inspiratory pressure as measure of respiratory muscle function
timeFrame: Pre-operative and Post operative day 1, 3 and 5
measure: Post operative fatigue
timeFrame: Pre-operative and Post operative day 1, 3, 5 and 28
measure: Quality of recovery (QOR)
timeFrame: Post operative day 1, 3 and 5
measure: Functioning at day 28
timeFrame: Pre-operative and Post operative day 28
measure: Coagulation disorder
timeFrame: postoperatively first 24 hours
measure: Sleeping pattern
timeFrame: 10 consecutive nights, starting 3 days before surgery
measure: Sleep quality
timeFrame: 3 days before and 10 days after surgery
measure: Sleep chronotype
timeFrame: 3 days before surgery
measure: Sleeping EEG pattern
timeFrame: first postoperative night
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
References: