- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704387
Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery (REVOLUTION)
Restrictive- vs. Individualized Assisted Fluid Management in Patients Undergoing Major Liver Resection Surgery: A Randomized Controlled Trial
"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."
Study Overview
Status
Conditions
Intervention / Treatment
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 "
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ALEXANDRE JOOSTEN, MD PhD
- Phone Number: 0145593802
- Email: alexandre.joosten@aphp.fr
Study Contact Backup
- Name: Jacques DURANTEAU, MD PhD
- Phone Number: 0145593802
- Email: jacques.duranteau@aphp.fr
Study Locations
-
-
VAL DE Marne
-
Villejuif, VAL DE Marne, France, 94800
- PAUL BROUSSE, centre hepato -biliaire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patient
- Major liver surgery
Exclusion Criteria:
-arrythmia -Linguistic barrier -Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: restrictive fluid therapy group
Patients in this group will have a restrictive fluid therapy (1 ml/kh/h) from anesthesia induction until end of liver resection.
|
from anesthesia induction until end of the liver resection, patient will have a restrictive fluid therapy strategy
|
Experimental: individualized GDFT group
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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lactate level at the end of the surgery
Time Frame: Up to the end of surgenry (intraoperatively)
|
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
Time Frame: Up to the end of surgenry (intraoperatively)
|
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
Time Frame: Up to the end of surgenry (intraoperatively)
|
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
Time Frame: end of the surgery
|
We will report the total amount of fluid used during surgery
|
end of the surgery
|
Incidence of acute kidney injury (AKI)
Time Frame: postoperative day 7
|
We will report the incidence of AKI at postoperative day 7 using the KDIGO classification
|
postoperative day 7
|
Incidence of postoperative complications
Time Frame: postoperative day 30
|
We will report the incidence of postoperative complications using the clavien dindo classification
|
postoperative day 30
|
Collaborators and Investigators
Investigators
- Principal Investigator: ALEXANDRE JOOSTEN, MD PhD, APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- APHP 220682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgery-Complications
-
Duke UniversityWithdrawnSurgical Complications From Surgery | Surgical Complications From Bladder Surgery | Surgical Complications From Bowel Surgery
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
-
University of KwaZuluMedical Research Council, South AfricaCompletedMortality | Surgery | Surgery- ComplicationsSouth Africa, Algeria, Benin, Burundi, Cameroon, Congo, The Democratic Republic of the, Congo, Egypt, Ethiopia, Gambia, Ghana, Kenya, Libyan Arab Jamahiriya, Madagascar, Mali, Mauritius, Namibia, Nigeria, Niger, Senegal, Tanzania, Tog... and more
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Western University, CanadaNot yet recruitingSurgery | Surgery--Complications | Pulmonary Complication
-
Faiza GabaQueen Mary University of London; University of Hertfordshire; University of Aberdeen and other collaboratorsRecruitingGynecologic Cancer | Surgery | Surgery--ComplicationsUnited Kingdom
-
Hacettepe UniversityCompletedSurgery--Complications | Newborn Morbidity | Neonatal SurgeryTurkey
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Hospices Civils de LyonRecruitingPost-operative Complications After Colorectal Surgery | Post-operative Complications After Gastric Surgery | Post-operative Complications After Bariatric SurgeryFrance
-
Henan Cancer HospitalThe First Affiliated Hospital of Zhengzhou University; Henan Provincial People... and other collaboratorsRecruitingSurgery--ComplicationsChina
Clinical Trials on Restrictive fluid therapy strategy
-
Assiut UniversityCompleted
-
Cairo UniversityCompletedPost-Dural Puncture HeadacheEgypt
-
Centre hospitalier de l'Université de Montréal...Canadian Institutes of Health Research (CIHR); Canadian Donation and Transplantation... and other collaboratorsRecruiting
-
Assiut UniversityUnknownHepatic Complication
-
Guangdong Provincial People's HospitalNot yet recruitingValve Heart Disease | Cardiac Surgery With Cardiopulmonary BypassChina
-
AC Camargo Cancer CenterNot yet recruitingSurgery | Critical Care | Oncology | TransfusionBrazil
-
Karaman Training and Research HospitalCompletedPostoperative Nausea and VomitingTurkey
-
Bayside HealthNational Health and Medical Research Council, AustraliaCompletedAbdominal SurgeryAustralia
-
Unity Health TorontoRecruitingCardiac Surgery | Heart | Postoperative | DisorderCanada, Russian Federation
-
University of Sao PauloCompleted