AHA STEROID trial, dexamethasone in acute high-risk abdominal surgery, the protocol for a randomized controlled trial.

Abstract

Existing multimodal pathways for patients undergoing acute high-risk abdominal surgery for intestinal obstruction (IO) and perforated viscus (PV) have focused on rescue in the immediate perioperative period. However, there is little focus on the peri-operative pathophysiology of recovery in this patient group, as done to develop enhanced recovery pathways in elective care. Acute inflammation is the main driver of the perioperative pathophysiology leading to adverse outcomes. Pre-operative high-dose of glucocorticoids provides a reduction in the inflammatory response after surgery, effective pain relief in several major surgical procedures, as well as reduce fatigue and improving endothelial dysfunction. To evaluate the effect of high-dose glucocorticoid on the inflammatory response, fluid distribution and recovery after acute high-risk abdominal surgery in patients with IO and PV. AHA STEROID trial is a sponsor-initiated single-center, randomized, double-blind placebo-controlled trial, assessing preoperative high-dose dexamethasone (1mg/kg) versus placebo (normal saline) in patients undergoing emergency high-risk abdominal surgery. We plan to enroll 120 patients. Primary outcome is the reduction in C-reactive protein on postoperative day 1 as a marker of successful attenuation of the acute stress response. Secondary outcomes include perioperative changes in endothelial and other inflammatory markers, fluid distribution, pulmonary function, pain, fatigue, and mobilization. The statistical plan is outlined in the protocol. The AHA STEROID trial will provide important evidence to guide the potential use of high-dose glucocorticoids in emergency high-risk abdominal surgery, with respect to different pathophysiologies.