Effect of Corticosteroids on Recovery After Major Surgery in Elderly Patients
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
This study tests if giving a single high dose of corticosteroids can help older patients recover better after major surgery by reducing complications like muscle weakness and fatigue.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 672 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Ziekenhuis Oost-Limburg Academic / other |
| Locations | 1 site (Genk) |
| Trial ID | NCT05220319 on ClinicalTrials.gov |
What this trial studies
The CORTERAS study investigates how a single high dose of corticosteroids can influence recovery outcomes in elderly patients undergoing major surgery. It focuses on reducing the systemic inflammatory response that often leads to post-operative complications such as muscle weakness and fatigue. By comparing patients receiving corticosteroids to those who do not, the study aims to determine if this intervention can enhance the quality of recovery and reduce post-operative morbidity. The trial specifically targets patients aged 60 and older who are scheduled for various elective surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 60 years or older scheduled for specific elective surgical procedures.
Not a fit: Patients undergoing urgent surgeries or those with preexisting muscle diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve recovery times and quality of life for elderly patients after major surgery.
How similar studies have performed: While corticosteroids have been studied for various inflammatory conditions, this specific application in post-operative recovery for elderly patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Genk
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
Study contacts
- Study coordinator: Steven Thiessen
- Email: steven.thiessen@zol.be
- Phone: 003289325294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.