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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03012919
Enrollment
31
Registered
2017-01-06
Start date
2015-02-28
Completion date
2016-06-30
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Decision Support System, Feasibility, Goal Directed Therapy

Keywords

active decision support system, goal directed therapy, Lidco, vascular surgery, hemodynamic optimization

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.

Interventions

OTHERactive 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).

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of interventions done according to the active decision support system (GDT protocol)through study completion, an average of 6 monthsThe number of interventions done according to the active decision support system (GDT protocol) is calculated.
duration of use of active decision support systemthrough study completion, an average of 6 monthsThe absolute duration of use and relative duration of use (in relation to the duration of surgery) of the active decision support system are calculated.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026