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Closed-Loop Titration of Vasopressor Infusions: Feasibility Study or Proof of Concept Study (CLV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03515161
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : September 14, 2018
Information provided by (Responsible Party):
Alexandre Joosten, Erasme University Hospital

Brief Summary:
The purpose of this study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac or Clearsight system, Edwards Lifesciences, IRVINE, USA).

Condition or disease Intervention/treatment Phase
Closed-Loop Communication Hemodynamic Instability Device: closed-loop Not Applicable

Detailed Description:

In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 65mmHg). The target MAP will be set at 70mmHg, except for neuro embolisation case where MAP can be higher. The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.

The Investigators have shown this to be the case in simulation studies and in-vivo animal studies (under submission) but not yet experimentally in a clinical setting. Investigators will recruit their patients from the surgical record that that require a mini-invasive or a non-invasive cardiac output monitoring (EV1000 monitoring using the Flotrac or clearsight system) ; either high risk patients undergoing high risk surgery (vascular-cardiac- Major Abdominal or renal transplant, neuro-endo-vascular surgery (aneuvrysm) and require mechanical ventilation and consent to participate in the study will be included in the study.

The investigators will also test the system in a short series of patients in the ICU setting ( critically ill patients): ideally in 3-4 "types" of patients ( septic patients, neuro ICU patients, ARDS patients and postoperative patients( ideally intubated patients or sedated patients) .The target mean arterial pressure can be different from the 70 mmHg of the surgical patients especially for the neurologic patients (head trauma injury patients or neuro-endovascular surgical patients). In these two subgroups of patients, the target MAP can even vary during the case depending on the surgeons requests (neuro radiologists) or depending on cerebral autoregulation.

Participants 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 vasopressor administration. Fluids will be given as goal directed therapy using the assisted fluid management software present in the EV1000 monitor (only for vascular and abdominal cases).

The closed loop (automated) system 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 vasopressor infusion rate the patient receives using feedback from standard operating room monitors at ERASME HOSPITAL Data from this study will also be retrospectively compared to subjects case matched to evaluate differences in MAP time in target, total amount of vasopressor received, and patient outcomes (for patients undergoing high risk surgery and/or neuro endovascular patients)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: SINGLE GROUP ASSIGNMENT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer-assisted Vasopressor Infusion for Hemodynamic Optimization in Patients Undergoing High Risk Surgery
Actual Study Start Date : April 26, 2018
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

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 manually using the assisted fluid management sofware from the EV1000 monitor. A closed-loop system will automatically administer vasopressor based on the predefined target MAP chosen by the anesthesiologist in charge of the patient
Device: closed-loop
Vasopressor admnistration 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 vasopressor the patient receives using feedback from standard operating room monitors.

Primary Outcome Measures :
  1. Percentage of case Time in hypotension (MAP <65 mmHg) for surgical patients. For potential recrutment of critically ill patients in the ICU, this target can be different (higher, depending on the type of patient and comorbidities) [ Time Frame: At postoperative day 1 ]
    The primary outcome will be the percentage of case time in predefined MAP target

Secondary Outcome Measures :
  1. percentage of case time with MAP >75 mmHg with norepinephrine still running [ Time Frame: At postoperative day 1 ]

  2. Amount of vasopressors received [ Time Frame: At postoperative day 1 ]
    Amount of vasopressors received

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects over the age of 18
  • Subjects undergoing elective high risk surgery (either vascular-cardiac- or transplant)
  • Subjects requiring general anesthesia and mechanical ventilation
  • Subjects requiring cardiac output monitoring with 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
  • Subject with Atrial Fibrillation
  • 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 identifier (NCT number): NCT03515161

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Brussel, Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
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Principal Investigator: Alexandre Joosten, M.D Erasme
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alexandre Joosten, Principal Investigator, Erasme University Hospital Identifier: NCT03515161    
Other Study ID Numbers: P2018/276
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We can provide individual patients data ( all hemodynamic data)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After the completion of the study and the publication of the results
Access Criteria: Contact PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alexandre Joosten, Erasme University Hospital: