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

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ClinicalTrials.gov Identifier: NCT01950845
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
University of California, Irvine
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Colorectal Surgery Hepatectomy Pancreatectomy Pancreaticoduodenectomy Device: Closed loop automated System (LIR®: learning intravenous resuscitator) Device: manual current practice by anesthesiologist team Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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.
Study Start Date : February 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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.




Primary Outcome Measures :
  1. Mean indexed cardiac output [ Time Frame: J1 to J12 (Within the surgical hospital length of stay) ]

Secondary Outcome Measures :
  1. per operative hemodynamic parameter [ Time Frame: J1 (per operative time) ]
  2. Per operative fluid administration [ Time Frame: J1 (per operative) ]
  3. Hospital length of stay [ Time Frame: J1 to J12 ]
    Within the surgical hospital length of stay

  4. Occurrence of a adverse event after surgery [ Time Frame: an expected average of 12 days ]
    Within the surgical hospital length of stay

  5. Occurrence of a death whatever the cause [ Time Frame: an expected average of 12 days ]
    Within the surgical hospital length of stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950845


Locations
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France
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France, 69 495
Sponsors and Collaborators
Hospices Civils de Lyon
University of California, Irvine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01950845    
Other Study ID Numbers: 2012.770
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery