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Completed

NCT Number: NCT04357301

Tight Closed-loop Systolic Arterial Pressure Control

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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme

Brussels, 1070, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop vasopressor

Device

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

Primary outcomes

  1. Percentage of case Time in hypotension (SAP <117 mmHg)

    Time frame: 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 outcomes

  1. Amount of vasopressors received

    Time frame: At postoperative day 1

    Amount of vasopressors received (norepinephrine)

  2. Number of vasopressors infusion rate modifications

    Time frame: At postoperative day 1

    Number of vasopressors infusion rate modifications

  3. Percentage of case time with a MAP < 65 mmHg

    Time frame: At postoperative day 1

    Percentage of case time with a MAP < 65 mmHg

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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