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OpenTrials
Completed

NCT Number: NCT01950845

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69 495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed loop automated System (LIR®: learning intravenous resuscitator)

Device

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

Device

The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.

Primary outcomes

  1. Mean indexed cardiac output

    Time frame: J1 to J12 (Within the surgical hospital length of stay)

Secondary outcomes

  1. per operative hemodynamic parameter

    Time frame: J1 (per operative time)

  2. Per operative fluid administration

    Time frame: J1 (per operative)

  3. Hospital length of stay

    Time frame: J1 to J12

    Within the surgical hospital length of stay

  4. Occurrence of a adverse event after surgery

    Time frame: an expected average of 12 days

    Within the surgical hospital length of stay

  5. Occurrence of a death whatever the cause

    Time frame: an expected average of 12 days

    Within the surgical hospital length of stay

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • University of California, Irvine

Registry information

Official study 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.

Acronym: CL vs CP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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