Closed-Loop Fluid Administration System Using Hemodynamic Monitors

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02020863
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 17.9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Nov 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Fluid Status During Surgery [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%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine Medical Center	Orange	California	United States	92858

Sponsors and Collaborators

• University of California, Irvine

Investigators

• Principal Investigator: Maxime Cannesson, MD, PhD, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related info

Publications

• Bednarski P, Siclari F, Voigt A, Demertzis S, Lau G. Use of a computerized closed-loop sodium nitroprusside titration system for antihypertensive treatment after open heart surgery. Crit Care Med. 1990 Oct;18(10):1061-5.
• Blankenship HB, Wallace FD, Pacifico AD. Clinical application of closed-loop postoperative autotransfusion. Med Prog Technol. 1990 May;16(1-2):89-93.
• Bowman RJ, Westenskow DR. A microcomputer-based fluid infusion system for the resuscitation of burn patients. IEEE Trans Biomed Eng. 1981 Jun;28(6):475-9.
• Chaisson NF, Kirschner RA, Deyo DJ, Lopez JA, Prough DS, Kramer GC. Near-infrared spectroscopy-guided closed-loop resuscitation of hemorrhage. J Trauma. 2003 May;54(5 Suppl):S183-92.
• Colvin JR, Kenny GN. Development and evaluation of a dual-pump microcomputer-based closed-loop arterial pressure control system. Int J Clin Monit Comput. 1989 Jan;6(1):31-5.
• DeBey RK, Westenskow DR, Jordan WS, McJames SW. A urine based control system for fluid infusion. Biomed Sci Instrum. 1987;23:195-8.
• Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
• Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. Epub 2005 Nov 8.
• Rinehart J, Alexander B, Le Manach Y, Hofer C, Tavernier B, Kain ZN, Cannesson M. Evaluation of a novel closed-loop fluid-administration system based on dynamic predictors of fluid responsiveness: an in silico simulation study. Crit Care. 2011;15(6):R278. doi: 10.1186/cc10562. Epub 2011 Nov 23.
• Rinehart J, Chung E, Canales C, Cannesson M. Intraoperative stroke volume optimization using stroke volume, arterial pressure, and heart rate: closed-loop (learning intravenous resuscitator) versus anesthesiologists. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):933-9. doi: 10.1053/j.jvca.2012.05.015. Epub 2012 Jul 12.
• Rinehart J, Lee C, Canales C, Kong A, Kain Z, Cannesson M. Closed-loop fluid administration compared to anesthesiologist management for hemodynamic optimization and resuscitation during surgery: an in vivo study. Anesth Analg. 2013 Nov;117(5):1119-29. doi: 10.1213/ANE.0b013e3182937d61.
• Rinehart J, Lee C, Cannesson M, Dumont G. Closed-loop fluid resuscitation: robustness against weight and cardiac contractility variations. Anesth Analg. 2013 Nov;117(5):1110-8. doi: 10.1213/ANE.0b013e3182930050.
• Rinehart J, Liu N, Alexander B, Cannesson M. Review article: closed-loop systems in anesthesia: is there a potential for closed-loop fluid management and hemodynamic optimization? Anesth Analg. 2012 Jan;114(1):130-43. doi: 10.1213/ANE.0b013e318230e9e0. Epub 2011 Sep 29. Review.

• Responsible Party: Maxime Cannesson, Professor, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT02020863
• Other Study ID Numbers: UCIANES03
• First Posted: Dec 25, 2013
• Last Update Posted: May 27, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Postoperative Complications

Study Results

Participant Flow

Arm/Group Title	Closed Loop
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	40
COMPLETED	35
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Closed Loop
Arm/Group Description	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. 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.
Overall Participants	35
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 65.7%
>=65 years	12 34.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.6 (12.8)
Sex: Female, Male (Count of Participants)
Female	16 45.7%
Male	19 54.3%
Region of Enrollment (participants) [Number]
United States	35 100%
Specific Surgical procedure (participants) [Number]
Whipple	9 25.7%
Whipple + additional	8 22.9%
Distal pancreatectomy	5 14.3%
Liver resection	10 28.6%
Complex cholecystectomy	3 8.6%
ASA Physical Status patient classification (participants) [Number]
2	1 2.9%
3	28 80%
4	6 17.1%
Stroke Volume Index (ml per meter-squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml per meter-squared]	44 (10)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Closed Loop Study population at Stroke Volume Variation (SVV) ≤12%

Arm/Group Title	Closed Loop
Arm/Group Description	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. 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.
Measure Participants	40
Mean (Standard Deviation) [percentage of case time]	95 (6)

Adverse Events

Arm/Group Title	Closed Loop
Arm/Group Description	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. 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.
All Cause Mortality
	Closed Loop
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Closed Loop
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	Closed Loop
	Affected / at Risk (%)	# Events
Total	0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.