Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69 495, France
NCT Number: NCT01950845
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pierre-Bénite, 69 495, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.
Time frame: J1 to J12 (Within the surgical hospital length of stay)
Time frame: J1 (per operative time)
Time frame: J1 (per operative)
Time frame: J1 to J12
Within the surgical hospital length of stay
Time frame: an expected average of 12 days
Within the surgical hospital length of stay
Time frame: an expected average of 12 days
Within the surgical hospital length of stay
Hospices Civils de Lyon
Other
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.
Acronym: CL vs CP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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