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Clinical Trials/NCT01950845
NCT01950845
Completed
Not Applicable

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.

Hospices Civils de Lyon1 site in 1 country46 target enrollmentFebruary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Abdominal Surgery
Sponsor
Hospices Civils de Lyon
Enrollment
46
Locations
1
Primary Endpoint
Mean indexed cardiac output
Status
Completed
Last Updated
4 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 1, 2014
End Date
October 1, 2015
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Mean indexed cardiac output

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

Secondary Outcomes

  • 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 Sites (1)

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