Abstract

BackgroundGoal directed therapy (GDT) is able to improve mortality and reduce complications in selected high-risk patients undergoing major surgery. The aim of this study is to compare two different strategies of perioperative hemodynamic optimization: one based on optimization of preload using dynamic parameters of fluid-responsiveness and the other one based on estimated oxygen extraction rate (O2ER) as target of hemodynamic manipulation.MethodsThis is a multicenter randomized controlled trial. Adult patients undergoing elective major open abdominal surgery will be allocated to receive a protocol based on dynamic parameters of fluid-responsiveness or a protocol based on estimated O2ER. The hemodynamic optimization will be continued for 6 h postoperatively. The primary outcome is difference in overall postoperative complications rate between the two protocol groups. Fluids administered, fluid balance, utilization of vasoactive drugs, hospital length of stay and mortality at 28 day will also be assessed.DiscussionAs a predefined target of cardiac output (CO) or oxygen delivery (DO2) seems to be not adequate for every patient, a personalized therapy is likely more appropriate. Following this concept, dynamic parameters of fluid-responsiveness allow to titrate fluid administration aiming CO increase but avoiding fluid overload. This approach has the advantage of personalized fluid therapy, but it does not consider if CO is adequate or not. A protocol based on O2ER considers this second important aspect. Although positive effects of perioperative GDT have been clearly demonstrated, currently studies comparing different strategies of hemodynamic optimization are lacking.Trial registrationClinicalTrials.gov, NCT04053595. Registered on 12/08/2019.

Highlights

  • Goal directed therapy (GDT) is able to improve mortality and reduce complications in selected highrisk patients undergoing major surgery

  • Dynamic parameters of fluid-responsiveness allow to titrate fluid administration aiming cardiac output (CO) increase but avoiding fluid overload

  • A protocol based on O2ER considers this second important aspect

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Summary

Introduction

Goal directed therapy (GDT) is able to improve mortality and reduce complications in selected highrisk patients undergoing major surgery. Any surgical intervention is a trauma for the organism and a stress response is activated to cope the external insult. This stress response is responsible of an increase in oxygen consumption. The same authors showed that the incidence of organ failure and mortality were reduced when oxygen debt was rapidly compensated using a protocol of hemodynamic optimization aiming to reach the same hemodynamic targets recorded in survived patients [1]. Several protocols have been developed to optimize hemodynamic parameters with the aim to reduce tissue hypoperfusion coming from maldistribution or inadequate perfusion and meet the increased metabolic need as soon as possible

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