At a glance
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High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Methylprednisolone and Dexamethasone for Complication, Postoperative. Completed, enrolled 174 participants across 1 site.
Detailed Summary
Background: Several randomized clinical trials have shown beneficial effects of pre-operative glucocorticoids on post-operative complications. Studies on the effects of glucocorticoids on the postoperative recovery after liver-resection show significantly lower markers of infection and liver damage, and some studies have shown a shorter hospital stay. Studies on the effects in the immediate postoperative phase are lacking. Methods: Randomized, double-blind, controlled trial evaluating incidence of postoperative complications in the immediate postoperative phase (and during admission) after open liver surgery. Participants are randomized to either active treatment (methylprednisolone 10 mg/kg) or control (8 mg dexamethasone), administered just prior to surgery. All patients undergoing open liver resection at our institution are eligible. Included patients are stratified according to extent of surgery into minor (\<3 segments) or major (≥3 segments) group. Patients in major group participate in Substudy I (markers of endothelial damage). Patients operated between January and July 2018 participate in Substudy II (delirium).
Study Details
Timeline
Interventions
10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery
Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery