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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

Tracking Information
First Submitted Date  ICMJE September 17, 2013
First Posted Date  ICMJE September 26, 2013
Last Update Posted Date July 7, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
Mean indexed cardiac output [ Time Frame: J1 to J12 (Within the surgical hospital length of stay) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
  • per operative hemodynamic parameter [ Time Frame: J1 (per operative time) ]
  • Per operative fluid administration [ Time Frame: J1 (per operative) ]
  • Hospital length of stay [ Time Frame: J1 to J12 ]
    Within the surgical hospital length of stay
  • Occurrence of a adverse event after surgery [ Time Frame: an expected average of 12 days ]
    Within the surgical hospital length of stay
  • Occurrence of a death whatever the cause [ Time Frame: an expected average of 12 days ]
    Within the surgical hospital length of stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Major Abdominal Surgery
  • Colorectal Surgery
  • Hepatectomy
  • Pancreatectomy
  • Pancreaticoduodenectomy
Intervention  ICMJE
  • 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.
  • Device: manual current practice by anesthesiologist team
    The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Closed loop automated System (LIR®: learning intravenous resuscitator)
  • 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
    Intervention: Device: manual current practice by anesthesiologist team
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2013)
46
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01950845
Other Study ID Numbers  ICMJE 2012.770
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE University of California, Irvine
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP