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

Not Applicable

Completed

• Conditions: Feasibility; Goal Directed Therapy; Active Decision Support System
• Interventions: Other: active decision support system

• Registration Number: NCT03012919
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-08
• Study Completion: 2016-06
• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-17
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active decision support system (GDT protocol)	active decision support system	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).

Primary Outcome Measures

Name	Time	Method
number of interventions done according to the active decision support system (GDT protocol)	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	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.