Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery

Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and vasoactive agents. There have been many subsequent protocols to improve outcome in the operating room or in the ICU. These are mainly passive decision support systems. Active clinical decision support systems using fluid and pharmacologic agents to improve intraoperative hemodynamics are not really found.

The investigators developed an active clinical decision support system based on an institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid device.

The goal of the study was to check the feasibility of an active clinical decision support system to optimize hemodynamics during high risk vascular surgery based on the principles of GDT implementing fluid, vasopressors and inotropes.

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Key information

Conditions

Feasibility Active Decision Support System Goal Directed Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

elective major vascular surgery such as peripheral arterial surgery and open abdominal aortic surgery except for carotid artery surgery

Exclusion criteria

patients under 18 years of age
absence of cardiac sinus rhythm at induction of anesthesia

Treatment and study plan

active decision support system

Other

The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).

Other names: goal directed therapy (GDT) protocol

Primary outcomes

number of interventions done according to the active decision support system (GDT protocol)

Time frame: through study completion, an average of 6 months

The number of interventions done according to the active decision support system (GDT protocol) is calculated.
duration of use of active decision support system

Time frame: through study completion, an average of 6 months

The absolute duration of use and relative duration of use (in relation to the duration of surgery) of the active decision support system are calculated.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2016
First posted: Jan 6, 2017
Registry last updated: Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed