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Manual vs Closed-loop Control of Mean Arterial Pressure

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ClinicalTrials.gov Identifier: NCT04089644
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
University of California, Los Angeles
University of California, Irvine
Bicetre Hospital
Information provided by (Responsible Party):
Alexandre Joosten, MD PhD, Erasme University Hospital

Brief Summary:

Intraoperative hypotension can impact patient outcome. Vasopressors are usually used to correct hypotension and ensure adequate organ perfusion.

The investigators have recently developed an automated system (closed-loop system) to titrate vasopressor agents in surgical and intensive care patients.

The purpose of this study is to compare two strategies to correct hypotension:

  1. Control group = standard practice ( manually adjusted norepinephrine infusion)
  2. Intervention group = closed-loop (automated) vasopressor administration system will deliver norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac, Edwards Lifesciences, IRVINE, USA).

Condition or disease Intervention/treatment Phase
Hypotension Device: closed-loop system Device: Manual adjustment Not Applicable

Detailed Description:

In order to prevent the known postoperative complications of intraoperative hypotension, vasopressor agents are occasionally used to ensure adequate perfusion. These vasopressors are usually administered as sporadic intermittent boluses or manually adjusted infusions, but this practice requires considerable time and attention, potentially reducing the time available for other clinical obligations. To overcome this issue, the investigators have developed a closed-loop vasopressor (CLV) controller to potentially correct hypotension more efficiently. After completing extensive in-silico and in-vivo studies, the investigators aimed to conduct a randomized control trial comparing manual vasopressor adjustment versus closed-loop vasopressor adjustment in patients undergoing major surgeries.

The primary outcome will be the incidence of hypotension (defined as a mean arterial pressure < 5mmHg of the chosen target).

Participants in both groups 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.

Fluids will be standardized in both groups and will be given as a continuous baseline infusion of 3 ml/kg/h (balanced crystalloid solution) and additional fluid boluses (mini fluid challenges of 100 ml) as a goal directed fluid therapy strategy


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center prospective randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physician-Directed vs Computer-Assisted Norepinephrine Administration in Patients Undergoing Major Surgery: A Randomized Controlled Trial
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: manual group
Hypotension will be corrected by manual infusion of norepinephrine
Device: Manual adjustment

Vasopressor agents will be manually adjusted (standard practice).

Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)


Experimental: closed-loop group
Hypotension will be corrected by closed-loop control of norepinephrine infusion
Device: closed-loop system

Hypotension will be corrected by an automated system for vasopressor administration.

Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)





Primary Outcome Measures :
  1. Percentage of case Time in hypotension (MAP < 5mmHg of the chosen MAP target). [ Time Frame: At postoperative day 1 ]
    Undertreatment. Percentage of time during surgery in hypotension. The MAP used to define hypotension can differ for each patient (individualized approach)


Secondary Outcome Measures :
  1. Percentage of case time in hypertension (MAP > 5 mmHg of the chosen target) with norepinephrine still running [ Time Frame: during surgery ]
    Overtreatment. Percentage of time during surgery in hypertension

  2. Percentage of case time in target (+/- 5 mmHg) of the chosen MAP target [ Time Frame: during surgery ]
    percentage of time during surgery with a MAP +/- 5 mmHg of the chosen target.

  3. Amount of vasopressors received [ Time Frame: during surgery ]
    Amount of vasopressors received

  4. Uretral perfusion index during surgery [ Time Frame: during surgery ]
    Mean Uretral perfusion index during surgery

  5. Uretral perfusion index during the first 15 minutes of the surgery [ Time Frame: during surgery ]
    Mean Uretral perfusion index during the first 15 minutes of the surgery

  6. Uretral perfusion index during the last 15 minutes of the surgery [ Time Frame: during surgery ]
    Mean Uretral perfusion index during the last 15 minutes of the surgery

  7. Cardiac index during surgery [ Time Frame: during surgery ]
    Mean cardiac index during surgery

  8. Stroke volume during surgery [ Time Frame: during surgery ]
    Mean Stroke volume during surgery

  9. Stroke volume variation during surgery [ Time Frame: during surgery ]
    Mean Stroke volume variation during surgery

  10. Amount of fluid received during surgery [ Time Frame: during surgery ]
    Amount of fluid received during surgery

  11. Net fluid balance during surgery [ Time Frame: during surgery ]
    Net fluid balance during surgery



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients undergoing major surgeries requiring an advanced cardiac output monitoring device (EV1000-Edwards LifeSciences, Irvine, USA) and a tight blood pressure control

Exclusion Criteria:

  • Atrial Fibrillation
  • Severe Arythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089644


Contacts
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Contact: Alexandre Joosten, MD PhD 003225553111 ext 003225553111 joosten-alexandre@hotmail.com
Contact: Dragos Chirnoaga, MD 003225553111 dragos.chirnoaga@gmail.com

Locations
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Belgium
Erasme Hospital Recruiting
Brussels, Brussel-hoofdstad, Belgium, 1070
Contact: Alexandre Joosten, MD PhD    025553111 ext 025553111    joosten-alexandre@hotmail.com   
Contact: Dragos Chirnoaga, MD    003225553111 ext 003225553111    dragos.chirnoaga@gmail.com   
Principal Investigator: Alexandre Joosten, MD PhD         
Sub-Investigator: Alexandra Colesnicenco, MD         
Sub-Investigator: Dragos Chirnoaga, MD         
Sponsors and Collaborators
Erasme University Hospital
University of California, Los Angeles
University of California, Irvine
Bicetre Hospital
Investigators
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Principal Investigator: Alexandre Joosten, MD PhD ERASME

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Responsible Party: Alexandre Joosten, MD PhD, Principal Investigator, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT04089644     History of Changes
Other Study ID Numbers: P2019/347
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents