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

Colorectal Surgery Clinical Trial

— CL vs CP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950845
• Other study ID #: 2012.770
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: July 6, 2016
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Surgery
• Hepatectomy
• Major Abdominal Surgery
• Pancreatectomy
• Pancreaticoduodenectomy

Intervention

Device:
• Closed loop automated System (LIR®: learning intravenous resuscitator)
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.
• manual current practice by anesthesiologist team
The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	University of California, Irvine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean indexed cardiac output		J1 to J12 (Within the surgical hospital length of stay)	No
Secondary	per operative hemodynamic parameter		J1 (per operative time)	No
Secondary	Per operative fluid administration		J1 (per operative)	No
Secondary	Hospital length of stay	Within the surgical hospital length of stay	J1 to J12	No
Secondary	Occurrence of a adverse event after surgery	Within the surgical hospital length of stay	an expected average of 12 days	No
Secondary	Occurrence of a death whatever the cause	Within the surgical hospital length of stay	an expected average of 12 days	No