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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04357301
Enrollment
12
Registered
2020-04-22
Start date
2020-09-25
Completion date
2020-10-30
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

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).

Interventions

DEVICEClosed-loop vasopressor

The system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single prospective pilot study (12 patients)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Amount of vasopressors receivedAt postoperative day 1Amount of vasopressors received (norepinephrine)
Number of vasopressors infusion rate modificationsAt postoperative day 1Number of vasopressors infusion rate modifications
Percentage of case time with a MAP < 65 mmHgAt postoperative day 1Percentage of case time with a MAP \< 65 mmHg

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026