Tight Closed-loop Systolic Arterial Pressure Control

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357301
• Other study ID #: P2020/157
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: March 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Closed-loop vasopressor
The system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients

Locations

Country	Name	City	State
Belgium	Erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amount of vasopressors received	Amount of vasopressors received (norepinephrine)	At postoperative day 1
Secondary	Number of vasopressors infusion rate modifications	Number of vasopressors infusion rate modifications	At postoperative day 1
Secondary	Percentage of case time with a MAP < 65 mmHg	Percentage of case time with a MAP < 65 mmHg	At postoperative day 1