Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05704387
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2022-07-28
Brief Title:
Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Restrictive- vs Individualized Assisted Fluid Management in Patients Undergoing Major Liver Resection Surgery A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVOLUTION
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
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 dissectionsurgical 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
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 dissectionsurgical 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None