search
Back to results

Computer Assisted Vasopressor Titration in Critically Ill Patients

Primary Purpose

Closed-Loop Communication

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
closed-loop system for vasopressor administration
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Closed-Loop Communication

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasme

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closed-loop

Arm Description

Pilot study: one single group of 10 ICU patients.

Outcomes

Primary Outcome Measures

Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target).
The primary outcome will be the percentage of case time in target

Secondary Outcome Measures

Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
Amount of vasopressors received
Amount of vasopressors received
Number of vasopressor modifications over the treatment time
Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time
Limitations of the closed-loop system
Number of errors, malfunction of the system during the treatment time

Full Information

First Posted
September 25, 2019
Last Updated
November 14, 2019
Sponsor
Erasme University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04106791
Brief Title
Computer Assisted Vasopressor Titration in Critically Ill Patients
Official Title
Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed-Loop Communication

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
SINGLE GROUP ASSIGNMENT
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed-loop
Arm Type
Experimental
Arm Description
Pilot study: one single group of 10 ICU patients.
Intervention Type
Device
Intervention Name(s)
closed-loop system for vasopressor administration
Intervention Description
The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.
Primary Outcome Measure Information:
Title
Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target).
Description
The primary outcome will be the percentage of case time in target
Time Frame
48 hours post-admission in the intensive care
Secondary Outcome Measure Information:
Title
Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Description
Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Time Frame
48 hours post-admission in the intensive care
Title
Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
Description
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
Title
Amount of vasopressors received
Description
Amount of vasopressors received
Time Frame
48 hours post-admission in the intensive care
Title
Number of vasopressor modifications over the treatment time
Description
Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time
Time Frame
48 hours post-admission in the intensive care
Title
Limitations of the closed-loop system
Description
Number of errors, malfunction of the system during the treatment time
Time Frame
48 hours post-admission in the intensive care

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre J MD, PhD
Organizational Affiliation
ERASME
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme
City
Brussels
State/Province
Anderlecht
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Computer Assisted Vasopressor Titration in Critically Ill Patients

We'll reach out to this number within 24 hrs