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

NCT05220319 | Completed Phase 4

• 1 other identifier: Z-2021070
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response; Weakness, Muscle

Outcome Measures

Primary Outcomes (1)

• 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

  Pre-operative and Post operative day 1

Secondary Outcomes (10)

• Post operative muscle weakness

  Pre-operative and Post operative day 1, 3 and 5

• Maximum inspiratory pressure as measure of respiratory muscle function

  Pre-operative and Post operative day 1, 3 and 5

• Post operative fatigue

  Pre-operative and Post operative day 1, 3, 5 and 28

• Quality of recovery (QOR)

  Post operative day 1, 3 and 5

• Functioning at day 28

  Pre-operative and Post operative day 28

Study Arms (2)

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.

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.

Drug: Methylprednisolone

Interventions

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.

Placebo

Methylprednisolone DRUG

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.

Methylprednisolone

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Methylprednisolone; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 2, 2022
• Study Start: February 16, 2022
• Primary Completion: September 30, 2025
• Study Completion: October 28, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)