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Assisted Fluid Management vs Manual GDFT

NCT ID: NCT03141411

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-10

Study Completion Date

2017-08-24

Brief Summary

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Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50%. To overpass this problem, our CO monitoring devices (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software. This software determines fluid responsiveness by estimating the predicted change in stroke volume and suggests to the anesthesiologist when fluid is required .

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Detailed Description

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The aim of this study was to assess an assisted fluid management strategy in a moderate-to-high risk surgical cohort and compare that cohort to matched patients who received manual GDFT. Our hypothesis was that the assisted fluid management system would result in higher mean percentage time spent during surgery with a SVV \< 13%

Conditions

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Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management

Exclusion Criteria

Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Joosten, M.D

Role: PRINCIPAL_INVESTIGATOR

Erasme

Locations

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Erasme

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Joosten A, Hafiane R, Pustetto M, Van Obbergh L, Quackels T, Buggenhout A, Vincent JL, Ickx B, Rinehart J. Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. J Clin Monit Comput. 2019 Feb;33(1):15-24. doi: 10.1007/s10877-018-0156-x. Epub 2018 May 19.

Reference Type DERIVED
PMID: 29779129 (View on PubMed)

Other Identifiers

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P2017/234 - B406201731981

Identifier Type: -

Identifier Source: org_study_id

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