Manual vs Closed-loop Control of Mean Arterial Pressure

NCT04089644 | Completed

• 1 other identifier: P2019/347
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 based on an individual definition of hypotension (therefore, the target MAP used to define hypotension will differ for each patient (individualized approach):

1. 1.Control group = standard practice ( manually adjusted norepinephrine infusion to correct hypotension and keep MAP within 90% of patient's baseline MAP
2. 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) to correct hypotension and keep MAP within 90% of patient's baseline MAP

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• Percentage of case Time in hypotension (MAP < 90% of the chosen MAP target).

  Undertreatment. Percentage of time during surgery in hypotension. The MAP used to define hypotension will differ for each patient (individualized approach)

  At postoperative day 1

Secondary Outcomes (11)

• Percentage of case time in hypotension (MAP < 65 mmHg)

  during surgery

• Percentage of case time in target (MAP +/- 10 mmHg) of the chosen MAP target

  during surgery

• Amount of vasopressors received

  during surgery

• Uretral perfusion index during surgery

  during surgery

• Uretral perfusion index during the first 15 minutes of the surgery

  during surgery

Study Arms (2)

manual group

ACTIVE COMPARATOR

Hypotension will be corrected by manual infusion of norepinephrine

Device: Manual adjustment

closed-loop group

EXPERIMENTAL

Hypotension will be corrected by closed-loop control of norepinephrine infusion

Device: closed-loop system

Interventions

closed-loop system DEVICE

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)

closed-loop group

Manual adjustment DEVICE

Vasopressor agents will be manually adjusted (standard practice). Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)

manual group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Atrial Fibrillation
• Severe Arythmia

Sponsors & Collaborators

• Erasme University Hospital: lead
• University of California, Los Angeles: collaborator
• University of California, Irvine: collaborator
• Bicetre Hospital: collaborator

Study Sites (1)

Erasme Hospital

Brussels, Brussel-hoofdstad, 1070, Belgium

Location

Related Publications (1)

• Joosten A, Chirnoaga D, Van der Linden P, Barvais L, Alexander B, Duranteau J, Vincent JL, Cannesson M, Rinehart J. Automated closed-loop versus manually controlled norepinephrine infusion in patients undergoing intermediate- to high-risk abdominal surgery: a randomised controlled trial. Br J Anaesth. 2021 Jan;126(1):210-218. doi: 10.1016/j.bja.2020.08.051. Epub 2020 Oct 8.

  PMID: 33041014 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexandre Joosten, MD PhD

  ERASME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center prospective randomized controlled trial

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: September 17, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)