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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01950845
Other study ID # 2012.770
Secondary ID
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


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
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