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

Civil Hospices of Lyon

Status: Completed

Conditions: Hepatectomy; Major Abdominal Surgery; Pancreaticoduodenectomy; Pancreatectomy; Colorectal Surgery

Treatments: Device: manual current practice by anesthesiologist team; Device: Closed loop automated System (LIR®: learning intravenous resuscitator)

Study type: Interventional

Funder types: Other

Identifiers

NCT01950845

2012.770

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Automated fluid management system (Closed-loop system)

Experimental group

Description:

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.

Treatment:

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

Current practice manual fluid management

Sham Comparator group

Description:

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

Treatment:

Device: manual current practice by anesthesiologist team