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Completed

NCT Number: NCT04106791

Computer Assisted Vasopressor Titration in Critically Ill Patients

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme

Brussels, Anderlecht, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

closed-loop system for vasopressor administration

Device

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

Primary outcomes

  1. Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target).

    Time frame: 48 hours post-admission in the intensive care

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

Secondary outcomes

  1. Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)

    Time frame: 48 hours post-admission in the intensive care

    Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)

  2. Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.

    Time frame: 48 hours post-admission in the intensive care

    Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.

  3. Amount of vasopressors received

    Time frame: 48 hours post-admission in the intensive care

    Amount of vasopressors received

  4. Number of vasopressor modifications over the treatment time

    Time frame: 48 hours post-admission in the intensive care

    Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time

  5. Limitations of the closed-loop system

    Time frame: 48 hours post-admission in the intensive care

    Number of errors, malfunction of the system during the treatment time

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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