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

NCT ID: NCT01950845

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-10-31

Brief Summary

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

Conditions

Major Abdominal Surgery; Colorectal Surgery; Hepatectomy; Pancreatectomy; Pancreaticoduodenectomy

Keywords

anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Closed loop automated System (LIR®: learning intravenous resuscitator)

Intervention Type: DEVICE

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.

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

Group Type: SHAM_COMPARATOR

manual current practice by anesthesiologist team

Intervention Type: DEVICE

The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.

Interventions

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.

Intervention Type: DEVICE

manual current practice by anesthesiologist team

The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 29380190 (View on PubMed)

Other Identifiers

2012.770

Identifier Type: -

Identifier Source: org_study_id