Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial

Not Applicable

Completed

• Conditions: Colorectal Surgery; Hepatectomy; Pancreaticoduodenectomy; Pancreatectomy; Major Abdominal Surgery
• Interventions: Device: manual current practice by anesthesiologist team

• Registration Number: NCT01950845
• Lead Sponsor: Hospices Civils de Lyon

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 available

Study Timeline

• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-26
• Study Start: 2014-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Current practice manual fluid management	manual current practice by anesthesiologist team	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

Primary Outcome Measures

Name	Time	Method
Mean indexed cardiac output	J1 to J12 (Within the surgical hospital length of stay)

Secondary Outcome Measures

Name	Time	Method
per operative hemodynamic parameter	J1 (per operative time)
Per operative fluid administration	J1 (per operative)
Hospital length of stay	J1 to J12	Within the surgical hospital length of stay
Occurrence of a adverse event after surgery	an expected average of 12 days	Within the surgical hospital length of stay
Occurrence of a death whatever the cause	an expected average of 12 days	Within the surgical hospital length of stay

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France