Tight Closed-loop Systolic Arterial Pressure Control

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: Closed-loop vasopressor

• Registration Number: NCT04357301
• Lead Sponsor: Erasme University Hospital

Brief Summary

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).

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 Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Study Start: 2020-09-25
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed-loop	Closed-loop vasopressor	Closed-loop administration of norepinephrine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of case time with a MAP < 65 mmHg	At postoperative day 1	Percentage of case time with a MAP \< 65 mmHg
Amount of vasopressors received	At postoperative day 1	Amount of vasopressors received (norepinephrine)
Number of vasopressors infusion rate modifications	At postoperative day 1	Number of vasopressors infusion rate modifications

Trial Locations

Locations (1)

Erasme; 🇧🇪 Brussels, Belgium