Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial

Andrea Carsetti, Mirco Amici, Tonino Bernacconi, Paolo Brancaleoni, Elisabetta Cerutti, Marco Chiarello, Diego Cingolani, Luisanna Cola, Daniela Corsi, Giorgio Forlini, Marina Giampieri, Salvatore Iuorio, Tiziana Principi, Giuseppe Tappatà, Michele Tempesta, Erica Adrario, Abele Donati, Andrea Carsetti, Mirco Amici, Tonino Bernacconi, Paolo Brancaleoni, Elisabetta Cerutti, Marco Chiarello, Diego Cingolani, Luisanna Cola, Daniela Corsi, Giorgio Forlini, Marina Giampieri, Salvatore Iuorio, Tiziana Principi, Giuseppe Tappatà, Michele Tempesta, Erica Adrario, Abele Donati

Abstract

Background: Goal 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.

Methods: This 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.

Discussion: As 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 registration: ClinicalTrials.gov, NCT04053595. Registered on 12/08/2019.

Keywords: Complications; Fluid-responsiveness; Oxygen extraction rate; Perioperative goal directed therapy.

Conflict of interest statement

The authors declare that they have no competing interests. The study has not received funding/assistance from any commercial organization.

Figures

Fig. 1
Fig. 1
Protocol A: Hemodynamic optimization protocol based on dynamic parameters of fluid responsiveness. PPV: pulse pressure variation; SVV: stroke volume variation
Fig. 2
Fig. 2
Protocol B: Hemodynamic optimization protocol based on estimated oxygen extraction rate. CVP: central venous pressure; O2ERe: oxygen extraction rate estimate; PPV: pulse pressure variation; SVV: stroke volume variation
Fig. 3
Fig. 3
Flow diagram
Fig. 4
Fig. 4
Study timeline

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