NCT04089644

Manual vs Closed-loop Control of Mean Arterial Pressure

Completed NA Last updated 10 March 2020

What this trial tests

NA trial testing closed-loop system in Hypotension in 30 participants. Completed in 5 March 2020.

Timeline

17 September 2019

Primary endpoint
5 March 2020

5 March 2020

Quick facts

Lead sponsor	Erasme University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	17 September 2019
Primary completion	5 March 2020
Estimated completion	5 March 2020
Sites	1 location across Belgium

Drugs / interventions tested

• closed-loop system
• Manual adjustment

Conditions studied

• Hypotension — all drugs for Hypotension →

Sponsor

Erasme University Hospital

Who can join

Adults 18 to 99, any sex, with Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Automated closed-loop versus manually controlled norepinephrine infusion in patients undergoing intermediate- to high-risk abdominal surgery: a randomised controlled trial.
   Joosten A, Chirnoaga D, Van der Linden P, Barvais L, et al · · 2021 · cited 33× · PMID 33041014 · DOI 10.1016/j.bja.2020.08.051