Computer Assisted Vasopressor Titration in Critically Ill Patients

NCT ID: NCT04106791

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2018-10-30

Brief Summary

The purpose of this pilot 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 Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.

Detailed Description

The investigators have developed an automated closed-loop system for vasopressor administration . They will test it in critically ill patients. The investigators want to demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the treatment time.

The Investigators have shown this to be the case in simulation studies and in-vivo animal studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring and under continuous norepinephrine infusion.

These patients will typically include: septic patients, neuro ICU patients, ARDS patients, trauma patients or postoperative patients.

The target MAP will be determined by the ICU physician in charge of the patient.

Fluids will be given standard of care. The closed loop (automated) system will use an infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor (norepinephrine)

The goal is to register a period of two hours of closed-loop control of MAP.

Conditions

Closed-Loop Communication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Closed-loop

Pilot study: one single group of 10 ICU patients.

Group Type: EXPERIMENTAL

closed-loop system for vasopressor administration

Intervention Type: DEVICE

The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.

Interventions

closed-loop system for vasopressor administration

The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ICU patients under norepinephrine administration and equipped with a advanced hemodynamic monitoring device

Exclusion Criteria

• Subjects under 18 years of age
• Subjects not requiring cardiac output monitoring or an arterial line
• Subject with Atrial Fibrillation
• Subjects who are pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Joosten, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre J MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ERASME

Locations

Erasme

Brussels, Anderlecht, Belgium

Countries

Belgium

Other Identifiers

P2018276

Identifier Type: -

Identifier Source: org_study_id