Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial

Study Overview
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Brief Summary
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Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups

Official Title
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Per Operative Fluid Optimisation Comparison of an Automated Closed-Loop System Versus Current Practice in High Risk Abdominal Surgical Patient. A Prospective, Randomized Clinical Trial.

Conditions
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Major Abdominal Surgery, Colorectal Surgery, Hepatectomy, Pancreatectomy, Pancreaticoduodenectomy

Intervention / Treatment
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* Device: Closed loop automated System (LIR®: learning intravenous resuscitator)
* Device: manual current practice by anesthesiologist team


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective major abdominal surgery Patient physical status ASA 2-4 General anesthesia with positive pressure ventilation High risk surgical patient with a per operative Vigileo® cardiac output monitoring decided a priori. Exclusion Criteria: Pregnant female Intraoperative hyperthermic chemotherapy procedure Patient physical status ASA more than 4 Patient with allergy to hydroxyethyl starch Cardiac arrhythmia ventilation with tidal volume inferior 7mL/Kg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated fluid management system (Closed-loop system)<br>cardiac output Vigileo® (Edwards Lifesciences) monitoring is connected to the closed loop system that will automatically provide per operative fluid bolus to optimize cardiac output by automated detection of fluid responsiveness state. | Device: Closed loop automated System (LIR®: learning intravenous resuscitator)<br>* Connection of the system to the patient under supervision of the anesthesiologist team during all the anesthesia procedure, respective of the applicability criteria for the fluid responsiveness detection.<br>|
| Sham Comparator: Current practice manual fluid management<br>cardiac output Vigileo® (Edwards Lifesciences) monitoring will be used to help the anesthesiologist team to detect fluid responsiveness state for the manual fluid management optimization | Device: manual current practice by anesthesiologist team<br>* The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean indexed cardiac output |  | J1 to J12 (Within the surgical hospital length of stay) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| per operative hemodynamic parameter |  | J1 (per operative time) | 
| Per operative fluid administration |  | J1 (per operative) | 
| Hospital length of stay | Within the surgical hospital length of stay | J1 to J12 | 
| Occurrence of a adverse event after surgery | Within the surgical hospital length of stay | an expected average of 12 days | 
| Occurrence of a death whatever the cause | Within the surgical hospital length of stay | an expected average of 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery