CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients

Phase

Condition

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Inflammation

Treatment

NaCl 0.9%

Methylprednisolone

Clinical Study ID

NCT05220319

Z-2021070

Ages > 60
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Lack of informed consent or inability to give informed consent.
Severe postoperative nausea & vomiting (PONV), needing corticosteroids as PONVprophylaxis.
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 beforesurgery 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 armor hand.

Study Design

NaCl 0.9%

February 16, 2022

October 28, 2025

Study 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.

Connect with a study center

Ziekenhuis Oost-Limburg
Genk,
Belgium
Site Not Available
Ziekenhuis Oost-Limburg
Genk 2797670,
Belgium
Site Not Available

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