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
|Condition or disease||Intervention/treatment||Phase|
|Intraoperative Volume Status Postoperative Complications||Device: Closed Loop||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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%.
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
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92858|
|Principal Investigator:||Maxime Cannesson, MD, PhD||University of California, Irvine|