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

Civil Hospices of Lyon logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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