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CompletedNCT03002129Updated May 18, 2018

FLuid Responsiveness Prediction Using EXtra Systoles

An interventional study of fluid challenge in Coronary Artery Bypass Graft, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Coronary Artery Bypass Graft
03

In context

Cardiac Complexes, Premature

79 studies on the registry are indexed under Cardiac Complexes, Premature; 13 are open to participants now.

This study's enrollment of 60 is below the median of 86 across 40 interventional studies indexed under Cardiac Complexes, Premature.

Browse Cardiac Complexes, Premature studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    fluid challenge

    Other: fluid challenge

Interventions

  • Otherfluid challenge

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

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What researchers measure

Primary outcomes

  1. fluid challenge response in stroke volume

    To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume

    Time frame: during operation

07

Study locations

1 site
  • Universitu Medical Center Groningen
    Groningen, 9713EZ, Netherlands
08

References and documents

Publications

  • 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. PubMed 31134474 ↗
  • 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. PubMed 30414054 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03002129
Lead sponsor
University Medical Center Groningen
Responsible party
Prof.dr.T.W.L.Scheeren (prof.dr., University Medical Center Groningen) — Principal investigator
First posted
Dec 23, 2016
Start date
Jan 2017
Primary completion
Jun 26, 2017
Completion
Sep 2017
Last update
May 18, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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