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Closed-Loop Fluid Administration System Using Hemodynamic Monitors

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ClinicalTrials.gov Identifier: NCT02020863
Recruitment Status : Completed
First Posted : December 25, 2013
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Maxime Cannesson, University of California, Irvine

Brief Summary:
The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid administration system to deliver fluids using feedback from standard operating room hemodynamic monitors. In standard anesthesia care the rate of IV fluid administration to the patient is determined by the anesthesiologist caring for the patient. In this study protocol, the rate of fluid administration will be determined instead by the closed-loop (automated) control system under the supervision of the anesthesiologist. The system will independently decide when to give fluid and at what rate; the supervising anesthesiologist will monitor the system to ensure appropriate volumes are being delivered and to intervene if necessary.

Condition or disease Intervention/treatment Phase
Intraoperative Volume Status Postoperative Complications Device: Closed Loop Not Applicable

Detailed Description:
In our protocol we will test the hypothesis that closed-loop fluid administration can maintain higher cardiac stroke volume (shown to improve patient outcomes after surgery) than anesthesiologist management. We have shown this to be the case in multiple simulation studies and in-vivo animal studies, but not yet experimentally in a clinical setting. Investigators will recruit their patients from the surgical record that that require cardiac output monitoring undergoing surgery and require mechanical ventilation and consent to participate in the study will be included in the study. They will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of fluid administration. Fluids are usually given to a patient based on the physician's discretion. As part of the study patients will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors at UCI). Data from this study will be retrospectively compared to subjects case matched to evaluate differences in cardiac output, total fluid given, and patient outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closed-Loop Fluid Administration System Using Hemodynamic Monitors
Study Start Date : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Closed Loop
Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.
Device: Closed Loop
Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.




Primary Outcome Measures :
  1. Fluid Status During Surgery [ Time Frame: Duration of Surgery, up to 8 hours ]
    The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects (over the age of 18)
  • Subjects undergoing elective major, abdominal surgery
  • Subjects requiring general anesthesia and mechanical ventilation
  • Subjects requiring cardiac output monitoring and an arterial line

Exclusion Criteria:

  • Subjects under 18 years of age
  • Subjects not undergoing surgery
  • Subjects not requiring general anesthesia or mechanical ventilation
  • Subjects not requiring cardiac output monitoring or an arterial line
  • Subjects who are pregnant
  • Subjects without the capacity to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020863


Locations
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United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92858
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Maxime Cannesson, MD, PhD University of California, Irvine
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maxime Cannesson, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02020863    
Other Study ID Numbers: UCIANES03
First Posted: December 25, 2013    Key Record Dates
Results First Posted: May 27, 2016
Last Update Posted: May 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes