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Manual vs Closed-loop Control of Mean Arterial Pressure

2019-09-19 03:56:41 | BioPortfolio

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).

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 using the assisted fluid management software present in the EV1000 monitor.

Study Design

Conditions

Hypotension

Intervention

closed-loop system, Manual adjustment

Location

Erasme Hospital
Brussels
Brussel-hoofdstad
Belgium
1070

Status

Recruiting

Source

Erasme University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-19T03:56:41-0400

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