MedTrace Logo

Manual vs Closed-loop Control of Mean Arterial Pressure

NCT04089644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-10

No results posted yet for this study

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. 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

Conditions

Interventions

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)

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)

Sponsors & Collaborators

Principal Investigators

  • Alexandre Joosten, MD PhD · ERASME

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2020-03-05
Completion
2020-03-05

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089644 on ClinicalTrials.gov