Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery
Condition: Surgery-Complications
Study type: Interventional

Summary: 
      "Low central venous pressure (low-CVP) or a restrictive fluid administration strategy is
      usually used worldwide during major liver resection surgery. Although individualized goal
      directed fluid therapy (GDFT) has been associated with reduced morbidity and mortality in
      major abdominal surgery, concerns remain on blood loss when applying GDFT in liver surgery.
      Indeed, GDFT could lead to a higher CVP with the risk of increased blood loss and reduced
      quality of the surgical field especially during liver dissection.

      Since evidence is scarce, this randomized controlled trial investigates the impact of a
      restrictive vs an individualized GDFT strategy assisted by an assisted fluid management (AFM)
      system on lactate level, blood loss, and postoperative morbidity including acute kidney
      injury (AKI) in major liver resections."
    

Detailed description: 
      Major liver resection surgery is a frequent but complex surgery with high morbidity, even in
      high activity centers. The morbidity is mainly related to the size of the liver resection and
      to bleeding, responsible for postoperative hepatocellular failure.

      Intraoperative fluid administration is a major component of the anesthetic strategy to
      optimize the hemodynamic status and peripheral tissue perfusion of the patient. However,
      high-level evidence recommendations are still lacking regarding the optimal fluid strategy in
      patients undergoing major liver resection.

      On the one hand, it has been accepted for decades that anesthetic management should focus on
      minimizing intraoperative bleeding by limiting fluid administration. The objective of a
      ""restrictive"" fluid strategy has often been to maintain a low central venous pressure
      (CVP), allowing to decrease the venous pressure at the level of the suprahepatic veins and
      the hepatic section. The lower this pressure, the more limited the bleeding by ""backflow"".
      This strategy is supported by surgeons because it allows them to maintain a relatively
      bloodless operating field (by reducing bleeding) and thus facilitates their
      dissection/surgical work. Under these conditions, however, an infusion of vasopressors is
      often necessary to maintain adequate perfusion pressure to all organs. In addition, a
      ""liberal"" fluid administration is often required after liver transection to compensate for
      blood loss and delayed vascular filling accumulated during most of the surgical procedure.
      This strategy therefore potentially exposes the patient to the deleterious effects of
      hypovolemia as reflected by an increase in blood lactate levels. Lactate is considered an
      indirect marker of the degree of tissue hypoperfusion.

      On the other hand, in high-risk abdominal surgery, the anesthesia community recommends a more
      ""individualized"" fluid strategy, based on the optimization of stroke volume also called
      ""goal directed fluid therapy"" (GDFT) with the aim of decreasing postoperative
      complications. It is now even possible to apply this strategy using a real time clinical
      decision support system (""assisted fluid management"" or AFM). However, the concept of GDFT
      assisted by AFM (GDFT-AFM) could possibly be accompanied by an increase in CVP and therefore
      intraoperative bleeding. However, to date, no randomized study has compared these 2 fluid
      therapy strategies (restrictive vs GDFT-AFM) on lactate level as the primary outcome "
    

Intervention name(s): individualized GDFT; Restrictive fluid therapy strategy
Intervention type(s): Procedure; Procedure
Intervention description(s): In this group, from anesthesia induction until skin closure, fluid will be given to the patients based on the recommandation of the AFM software in order to optimize patient's SV; from anesthesia induction until end of the liver resection, patient will have a restrictive fluid therapy strategy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled parallel superiority trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: liver; hemodynamic optimization