Clinical trial NCT01950845: Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Abdominal Surgery
Colorectal Surgery
Hepatectomy
Pancreatectomy
Pancreaticoduodenectomy
Keywords: anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2013-09-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Mean indexed cardiac output
timeFrame: J1 to J12 (Within the surgical hospital length of stay)
Secondary outcomes:
measure: per operative hemodynamic parameter
timeFrame: J1 (per operative time)
measure: Per operative fluid administration
timeFrame: J1 (per operative)
measure: Hospital length of stay
timeFrame: J1 to J12
measure: Occurrence of a adverse event after surgery
timeFrame: an expected average of 12 days
measure: Occurrence of a death whatever the cause
timeFrame: an expected average of 12 days
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Study officials:
References:
citation: Lilot M, Bellon A, Gueugnon M, Laplace MC, Baffeleuf B, Hacquard P, Barthomeuf F, Parent C, Tran T, Soubirou JL, Robinson P, Bouvet L, Vassal O, Lehot JJ, Piriou V. Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial. J Clin Monit Comput. 2018 Dec;32(6):993-1003. doi: 10.1007/s10877-018-0106-7. Epub 2018 Jan 27.