Clinical trial NCT03012919: Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery
Official title: Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility
Active Decision Support System
Goal Directed Therapy
Keywords: active decision support system
goal directed therapy
Lidco
vascular surgery
hemodynamic optimization
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of interventions done according to the active decision support system (GDT protocol)
timeFrame: through study completion, an average of 6 months
measure: duration of use of active decision support system
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Martin Dworschak, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Medical University of Vienna
name: Michael Hiesmayr, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Medical University of Vienna
name: Johannes Menger, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Arabella Fischer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333.
citation: Feldheiser A, Conroy P, Bonomo T, Cox B, Garces TR, Spies C; Anaesthesia Working Group of the Enhanced Recovery After Surgery (ERAS(R)) Society; Enhanced Recovery After Surgery Society. Development and feasibility study of an algorithm for intraoperative goaldirected haemodynamic management in noncardiac surgery. J Int Med Res. 2012;40(4):1227-41. doi: 10.1177/147323001204000402.
citation: Sondergaard S, Wall P, Cocks K, Parkin WG, Leaning MS. High concordance between expert anaesthetists' actions and advice of decision support system in achieving oxygen delivery targets in high-risk surgery patients. Br J Anaesth. 2012 Jun;108(6):966-72. doi: 10.1093/bja/aes037. Epub 2012 Mar 16.
citation: Sahota N, Lloyd R, Ramakrishna A, Mackay JA, Prorok JC, Weise-Kelly L, Navarro T, Wilczynski NL, Haynes RB; CCDSS Systematic Review Team. Computerized clinical decision support systems for acute care management: a decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes. Implement Sci. 2011 Aug 3;6:91. doi: 10.1186/1748-5908-6-91.