The effect of corticosteroids on early recovery after major surgery in elderly patients: the CORTERAS trial

INTRODUCTION Postoperative fatigue is a major complication after surgery. It is one of the most distressing problems reported by patients and also thought to be the main contributor to delayed recovery after surgery. This is especially important for older patients who are often suffering from frailty characterised by a decreased physiological reserve. Surgical stress and the associated acute inflammatory response may be the driver of this fatigue by inducing acquired postoperative muscle weakness leading to impaired functional recovery. Corticosteroids are known to dampen this peri-operative stress response. Therefore, this study will investigate whether muscle weakness and, consequently, fatigue and delayed recovery after surgery can be ameliorated by administering methylprednisolone. METHODS AND ANALYSIS The CORTERAS trial is a large monocentric, parallel-group, double-blind, randomised controlled trial comparing the administration of 250 mg of methylprednisolone or a placebo in adults 60 years or older and scheduled for major elective surgery. In on-pump cardiac surgical procedures, a repeat dose of 250 mg will be given on initiation of cardiac bypass to correct for dilution. The primary outcome is the percentage change of handgrip strength on day 1 after surgery. Secondary outcomes encompass peripheral limb muscle strength, normalised peripheral limb muscle strength, fatigue, early quality of recovery, respiratory muscle strength, pain scores, postoperative nausea and vomiting (PONV), quality of life and markers of inflammation. The sample size has been calculated as a total of 674 patients receiving the study intervention and reaching the primary endpoint. Randomisation is performed at the patient level using computer-generated block assignments. Stratification is based on type of surgery, sex (male or female), age (60 to 70 years or older than 70 years) and BMI (≤30 or >30 kg m −2 ). Patients and outcome assessors are blinded to the intervention assignment. Assessments are conducted pre-operatively, immediately postoperatively, during the hospital stay (postoperative days 1, 3 and 5), and on day 28 postoperatively. ETHICS AND DISSEMINATION Ethical approval has been obtained from the Independent Ethics Committee at Ziekenhuis Oost-Limburg in Genk, under protocol version 2.0 (1 November 2021), reference number Z-202170. The study has been registered at ClinicalTrials.gov (NCT05220319) on 31 January 2022 and the first patient was included on 6 February 2022. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER ClinicalTrials.gov NCT05220319