Tight Closed-loop Systolic Arterial Pressure Control

Tight Systolic Arterial Pressure Control Using a Closed-loop System for Vasopressor Infusion in Patients Undergoing High-risk Abdominal Surgery: A Proof-of-Concept Study

The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitoring (EV1000 monitoring device, Edwards Lifesciences, Irvine, USA).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Closed-loop vasopressor

Detailed Description

In this case series, the investigators will report the percentage of case time in hypotension (defined as systolic arterial pressure (SAP) < 117mmHg). The target mean arterial pressure (MAP) will be set at a SAP of 130mmHg in all patients. Definition of Hypotension is target SAP - 10% (130mmHg - 13 mmHg = 117 mmHg). We will use the same SAP target in all patients even if we used a modified definition of hypotension from the study of Futier and colleagues ( JAMA 2017). We won't use a individualized SAP for each patient but the same SAP target in all patients.

The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.

The Investigators have shown the system works well based on a target MAP but not yet using a target of SAP.

The investigators will test the system in a pilot study of 13 patients undergoing High-risk abdominal surgery which require the placement of a arterial catheter, the optimization of fluid therapy and a tight SAP control.

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 ( automatically delivery instead of manually adjustments)

Fluids will be given as goal directed fluid therapy in order to maintain stroke volume variation below 13% (hospital guidelines).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (age of >17)
• Elective high-risk abdominal surgery
• Patients with an arterial line and in whom a goal directed fluid therapy protocol is applied manually (administration of fluid bolus to maintain a stroke volume variation < 13%)

Exclusion Criteria:

• Atrial Fibrillation
• Pregnancy
• Subjects without the capacity to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Closed-loop; Closed-loop administration of norepinephrine	Device: Closed-loop vasopressor; The system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of case Time in hypotension (SAP <117 mmHg)	The primary outcome will be the percentage of case time in predefined SAP target (SAP of 130 mmHg -10 % = 117 mmHg)	At postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of vasopressors received	Amount of vasopressors received (norepinephrine)	At postoperative day 1
Number of vasopressors infusion rate modifications	Number of vasopressors infusion rate modifications	At postoperative day 1
Percentage of case time with a MAP < 65 mmHg	Percentage of case time with a MAP < 65 mmHg	At postoperative day 1

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2020
• Primary Completion (ACTUAL): October 30, 2020
• Study Completion (ACTUAL): October 30, 2020

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vasoconstrictor Agents
• Other Study ID Numbers: P2020/157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No