Personalized hemodynamic management targeting preoperative baseline cardiac index in high-risk patients having major abdominal surgery: rationale and design of the international multicenter randomized PELICAN trial.

BACKGROUND

Intraoperative hemodynamic management is intended to ensure adequate tissue perfusion and oxygen delivery and eventually help avoid organ injury. However, the optimal strategy for intraoperative hemodynamic management in patients having non-cardiac surgery remains unclear. We here report the protocol of a trial designed to test the hypothesis that personalized intraoperative hemodynamic management targeting preoperative baseline cardiac index reduces the incidence of a composite outcome of major postoperative complications and death within 7 days after surgery compared to routine hemodynamic management in high-risk patients having elective major abdominal surgery.

METHODS

The PELICAN trial is an international multicenter randomized trial in 1,128 high-risk patients having elective major abdominal surgery. The individual preoperative baseline cardiac index is determined with the patient being awake and resting in the supine position using noninvasive bioreactance. Patients are randomized to personalized hemodynamic management (intervention) or to routine hemodynamic management (control) during surgery. In patients assigned to personalized hemodynamic management, intraoperative cardiac index is maintained at least at the preoperative baseline cardiac index. In patients assigned to routine hemodynamic management, it is performed as per anesthesiologist preference (with blinded cardiac index monitoring). The primary outcome is the incidence of a composite outcome ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, severe infectious complications, and death within 7 days after surgery.

DISCUSSION: Our trial will determine whether personalized intraoperative hemodynamic management targeting preoperative baseline cardiac index reduces the incidence of major postoperative complications and death within 7 days in high-risk patients having elective major abdominal surgery compared to routine hemodynamic management.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05648279. Registered on 5 December 2022.