Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period
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).
Timeline
- Start
- 2017-12-11
- Primary completion
- 2020-08-28
- Completion
- 2020-09-28
Outcome
Missed primary endpoint
registry p = 0.213; Risk Ratio (RR) 0.859 (95% CI) 0.682 to 1.082; Fisher Exact NCT03403517 ↗
paper A high dose of preoperative glucocorticoids did not reduce acute postoperative complications after open liver resection compared with a standard dose. PMID 34480563 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 8 mg | Other |
| Subject | Methylprednisolone | Other / unclassified | 10 mg/kg | Other |