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

NCT01950845 | Completed DMC

• 1 other identifier: 2012.770
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean indexed cardiac output

  J1 to J12 (Within the surgical hospital length of stay)

Secondary Outcomes (5)

• per operative hemodynamic parameter

  J1 (per operative time)

• Per operative fluid administration

  J1 (per operative)

• Hospital length of stay

  J1 to J12

• Occurrence of a adverse event after surgery

  an expected average of 12 days

• Occurrence of a death whatever the cause

  an expected average of 12 days

Study Arms (2)

Automated fluid management system (Closed-loop system)

EXPERIMENTAL

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)

Current practice manual fluid management

SHAM COMPARATOR

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

Interventions

manual current practice by anesthesiologist team DEVICE

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

Current practice manual fluid management

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

Automated fluid management system (Closed-loop system)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• University of California, Irvine: collaborator

Study Sites (1)

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69 495, France

Location

Related Publications (1)

• 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.

  PMID: 29380190 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 26, 2013
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)