Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery

Study Overview
=================
Brief 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 

Official Title
-----------------
Restrictive- vs. Individualized Assisted Fluid Management in Patients Undergoing Major Liver Resection Surgery: A Randomized Controlled Trial

Conditions
-----------------
Surgery-Complications

Intervention / Treatment
-----------------
* Procedure: individualized GDFT
* Procedure: Restrictive fluid therapy strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Major liver surgery Exclusion Criteria: -arrythmia -Linguistic barrier -Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled parallel superiority trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: restrictive fluid therapy group<br>Patients in this group will have a restrictive fluid therapy (1 ml/kh/h) from anesthesia induction until end of liver resection. | Procedure: Restrictive fluid therapy strategy<br>* from anesthesia induction until end of the liver resection, patient will have a restrictive fluid therapy strategy<br>|
| Experimental: individualized GDFT group<br>In this group, from anesthesia induction until skin closure, fluid will be given to the patients based on the recommendation of the AFM software in order to optimize patient's stroke volume (SV) | Procedure: individualized GDFT<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate level at the end of the surgery | lactate level measured at the end of the surgery (skin closure) | Up to the end of surgenry (intraoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intraoperative blood loss | We will measure blood loss at the end of the surgery | Up to the end of surgenry (intraoperatively) | 
| Total amount of vasopressors used during surgery | We will report the total amount of vasopressor used during surgery | Up to the end of surgenry (intraoperatively) | 
| Total amount of fluid used during surgery | We will report the total amount of fluid used during surgery | end of the surgery | 
| Incidence of acute kidney injury (AKI) | We will report the incidence of AKI at postoperative day 7 using the KDIGO classification | postoperative day 7 | 
| Incidence of postoperative complications | We will report the incidence of postoperative complications using the clavien dindo classification | postoperative day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver, hemodynamic optimization