Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial (CL vs CP)

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.

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

Study Overview

• Status: Completed
• Conditions: Hepatectomy; Colorectal Surgery; Pancreaticoduodenectomy; Major Abdominal Surgery; Pancreatectomy
• Intervention / Treatment: Device: Closed loop automated System (LIR®: learning intravenous resuscitator); Device: manual current practice by anesthesiologist team

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69 495
    • Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated fluid management system (Closed-loop system); 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); 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.
Sham Comparator: Current practice manual fluid management; 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; The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: University of California, Irvine

Publications and helpful links

General Publications

• Lilot M, Bellon A, Gueugnon M, Laplace MC, Baffeleuf B, Hacquard P, Barthomeuf F, Parent C, Tran T, Soubirou JL, Robinson P, Bouvet L, Vassal O, Lehot JJ, Piriou V. Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial. J Clin Monit Comput. 2018 Dec;32(6):993-1003. doi: 10.1007/s10877-018-0106-7. Epub 2018 Jan 27.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimated): September 26, 2013

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery
• Other Study ID Numbers: 2012.770