Intraoperative Volume StatusNCT02020863
Closed-Loop Fluid Administration System Using Hemodynamic Monitors
A study testing Closed Loop in people with Intraoperative Volume Status and Postoperative Complications, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Volume Status, Postoperative Complications
- What is being tested?
- Closed Loop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92858
About this study
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.
Read the 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.
- Being tested
- Closed Loop
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed LoopDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop | Experimental | 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. Receives: Device: Closed Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Status During Surgery
The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.
Measured: Duration of Surgery, up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Intraoperative Volume StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxime Cannesson, University of California, Irvine
- Investigators
- Maxime Cannesson, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020863
- Sponsor's protocol ID
- UCIANES03
- Status last verified
- Apr 2016
- First submitted
- 19 Dec 2013
- Last updated
- 27 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 21965362Bednarski 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. doi: 10.1097/00003246-199010000-00002.
PubMed 2209031Colvin 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. doi: 10.1007/BF01723370.
PubMed 2723513Blankenship HB, Wallace FD, Pacifico AD. Clinical application of closed-loop postoperative autotransfusion. Med Prog Technol. 1990 May;16(1-2):89-93.
PubMed 2138701Bowman 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. doi: 10.1109/TBME.1981.324822. No abstract available.
PubMed 7287047Chaisson 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. doi: 10.1097/01.TA.0000064508.11512.28.
PubMed 12768123DeBey RK, Westenskow DR, Jordan WS, McJames SW. A urine based control system for fluid infusion. Biomed Sci Instrum. 1987;23:195-8. No abstract available.
PubMed 3607171Rinehart 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.
PubMed 22112587Rinehart 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.
PubMed 23835454Rinehart 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.
PubMed 23835453Pearse 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. doi: 10.1186/cc3887. Epub 2005 Nov 8.
PubMed 16356219Forget 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.
PubMed 20705785Rinehart 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.
PubMed 22795172Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.
PubMed 25888403Joosten A, Huynh T, Suehiro K, Canales C, Cannesson M, Rinehart J. Goal-Directed fluid therapy with closed-loop assistance during moderate risk surgery using noninvasive cardiac output monitoring: A pilot study. Br J Anaesth. 2015 Jun;114(6):886-92. doi: 10.1093/bja/aev002. Epub 2015 Feb 17.
PubMed 25690834
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Fluid Administration System Using Hemodynamic Monitors
- ClinicalTrials.gov ID
- NCT02020863
- Acronym / sponsor ID
- UCIANES03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Posted 27 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed Loop | Experimental | Device: Closed LoopStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed LoopFluid 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. | Device | Closed Loop |
Primary outcome
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%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21965362Rinehart 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.
- Background: PubMed 2209031Bednarski 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. doi: 10.1097/00003246-199010000-00002.
- Background: PubMed 2723513Colvin 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. doi: 10.1007/BF01723370.
- Background: PubMed 2138701Blankenship HB, Wallace FD, Pacifico AD. Clinical application of closed-loop postoperative autotransfusion. Med Prog Technol. 1990 May;16(1-2):89-93.
- Background: PubMed 7287047Bowman 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. doi: 10.1109/TBME.1981.324822. No abstract available.
- Background: PubMed 12768123Chaisson 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. doi: 10.1097/01.TA.0000064508.11512.28.
- Background: PubMed 3607171DeBey RK, Westenskow DR, Jordan WS, McJames SW. A urine based control system for fluid infusion. Biomed Sci Instrum. 1987;23:195-8. No abstract available.
- Background: PubMed 22112587Rinehart 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.
- Background: PubMed 23835454Rinehart 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.
- Background: PubMed 23835453Rinehart 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.
- Background: PubMed 16356219Pearse 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. doi: 10.1186/cc3887. Epub 2005 Nov 8.
- Background: PubMed 20705785Forget 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.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Cannesson, MD, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Loop in people with Intraoperative Volume Status and Postoperative Complications, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Status During Surgery (time frame: Duration of Surgery, up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020863, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.