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

East Limburg Hospital

Status and phase: Enrolling; Phase 4

Conditions: Weakness, Muscle; Inflammatory Response

Treatments: Drug: NaCl 0.9%; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05220319

Z-2021070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 672 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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672 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: NaCl 0.9%

Methylprednisolone

Active Comparator group

Description:

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.

Treatment:

Drug: Methylprednisolone