Status:
RECRUITING
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
Lead Sponsor:
Ziekenhuis Oost-Limburg
Conditions:
Inflammatory Response
Weakness, Muscle
Eligibility:
All Genders
60+ years
Phase:
PHASE4
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 aft...
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, th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT05220319
Start Date
February 3 2022
End Date
December 1 2025
Last Update
April 11 2024
Active Locations (1)
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1
Ziekenhuis Oost-Limburg
Genk, Belgium