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

NCT03515161 | Completed

• 1 other identifier: P2018/276
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Closed-Loop Communication; Hemodynamic Instability

Keywords

closedloop; vasopressor

Outcome Measures

Primary Outcomes (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)

  The primary outcome will be the percentage of case time in predefined MAP target

  At postoperative day 1

Secondary Outcomes (2)

• percentage of case time with MAP >75 mmHg with norepinephrine still running

  At postoperative day 1

• Amount of vasopressors received

  At postoperative day 1

Study Arms (1)

Closed-loop

EXPERIMENTAL

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

Interventions

closed-loop DEVICE

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.

Closed-loop

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

Related Publications (1)

• Joosten A, Alexander B, Duranteau J, Taccone FS, Creteur J, Vincent JL, Cannesson M, Rinehart J. Feasibility of closed-loop titration of norepinephrine infusion in patients undergoing moderate- and high-risk surgery. Br J Anaesth. 2019 Oct;123(4):430-438. doi: 10.1016/j.bja.2019.04.064. Epub 2019 Jun 27.

  PMID: 31255290 DERIVED

MeSH Terms

Conditions

Teach-Back Communication

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Alexandre Joosten, M.D

  Erasme

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: SINGLE GROUP ASSIGNMENT

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 3, 2018
• Study Start: April 26, 2018
• Primary Completion: August 27, 2018
• Study Completion: August 27, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the completion of the study and the publication of the results
• Access Criteria: Contact PI

Locations

BE (1)