FeasibilityNCT03012919
Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery
A study testing active decision support system in people with Feasibility and Active Decision Support System, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feasibility, Active Decision Support System, Goal Directed Therapy
- What is being tested?
- active decision support system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective major vascular surgery such as peripheral arterial surgery and open abdominal aortic surgery except for carotid artery surgery
Who cannot join
- patients under 18 years of age
- absence of cardiac sinus rhythm at induction of anesthesia
About this study
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.
- Being tested
- active decision support system
- Keywords
- active decision support system, goal directed therapy, Lidco, vascular surgery, hemodynamic optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active decision support systemOther
Also called goal directed therapy (GDT) protocol
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).
| Study group | Role | What they receive |
|---|---|---|
| active decision support system (GDT protocol) | 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). Receives: Other: active decision support system |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of interventions done according to the active decision support system (GDT protocol)
The number of interventions done according to the active decision support system (GDT protocol) is calculated.
Measured: through study completion, an average of 6 months
duration of use of active decision support system
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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FeasibilityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arabella Fischer, MD, Medical University of Vienna
- Investigators
- Martin Dworschak, Prof. Dr., Study director, Medical University of ViennaMichael Hiesmayr, Prof. Dr., Study director, Medical University of ViennaJohannes Menger, Dr., Principal investigator, Medical University of ViennaArabella Fischer, Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012919
- Sponsor's protocol ID
- 1967/2014
- Status last verified
- Jun 2017
- First submitted
- 30 Dec 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
Publications
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.
PubMed 21339436Feldheiser 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.
PubMed 22971475Sondergaard 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.
PubMed 22427342Sahota 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.
PubMed 21824385
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery
- ClinicalTrials.gov ID
- NCT03012919
- Acronym / sponsor ID
- 1967/2014
- Keywords
- active decision support system, goal directed therapy, Lidco, vascular surgery, hemodynamic optimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active decision support system (GDT protocol) | Other | Other: active decision support systemThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective major vascular surgery such as peripheral arterial surgery and open abdominal aortic surgery except for carotid artery surgery
Key exclusion criteria (2 listed)
- patients under 18 years of age
- absence of cardiac sinus rhythm at induction of anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active decision support systemAlso: goal directed therapy (GDT) protocolThe 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 | active decision support system (GDT protocol) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Background: PubMed 21339436Fitzgerald 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.
- Background: PubMed 22971475Feldheiser 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.
- Background: PubMed 22427342Sondergaard 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.
- Background: PubMed 21824385Sahota 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Dworschak, Prof. Dr. study director
Medical University of Vienna
Michael Hiesmayr, Prof. Dr. study director
Medical University of Vienna
Johannes Menger, Dr. principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing active decision support system in people with Feasibility and Active Decision Support System, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of interventions done according to the active decision support system (GDT protocol) (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03012919, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.