FLuid Responsiveness Prediction Using EXtra Systoles

NCT ID: NCT03002129

Last Updated: 2018-05-18

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

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-09-30

Brief Summary

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In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.

Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids

Detailed Description

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Conditions

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Coronary Artery Bypass Graft

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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fluid challenge

Group Type OTHER

fluid challenge

Intervention Type OTHER

At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes

Interventions

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fluid challenge

At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients requiring elective CABG or OPCAB surgery
* Patient's age ≥ 18 years

Exclusion Criteria

* Patient refusal
* Pregnancy
* EF \< 35%
* End stage kidney failure (defined by the need for haemodialysis)
* Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Prof.dr.T.W.L.Scheeren

prof.dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitu Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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Holmgaard F, Vistisen ST, Ravn HB, Scheeren TWL. The response of a standardized fluid challenge during cardiac surgery on cerebral oxygen saturation measured with near-infrared spectroscopy. J Clin Monit Comput. 2020 Apr;34(2):245-251. doi: 10.1007/s10877-019-00324-w. Epub 2019 May 28.

Reference Type DERIVED
PMID: 31134474 (View on PubMed)

Vistisen ST, Berg JM, Boekel MF, Modestini M, Bergman R, Jainandunsing JS, Mariani MA, Scheeren TWL. Using extra systoles and the micro-fluid challenge to predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2019 Oct;33(5):777-786. doi: 10.1007/s10877-018-0218-0. Epub 2018 Nov 9.

Reference Type DERIVED
PMID: 30414054 (View on PubMed)

Other Identifiers

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FLEx study

Identifier Type: -

Identifier Source: org_study_id

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