FLuid Responsiveness Prediction Using EXtra Systoles
1 other identifier
interventional
60
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMay 18, 2018
May 1, 2018
6 months
December 15, 2016
May 15, 2018
Conditions
Outcome Measures
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
during operation
Study Arms (1)
fluid challenge
OTHERInterventions
At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes
Eligibility Criteria
You may qualify if:
- Patients requiring elective CABG or OPCAB surgery
- Patient's age ≥ 18 years
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitu Medical Center Groningen
Groningen, 9713EZ, Netherlands
Related Publications (2)
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.
PMID: 31134474DERIVEDVistisen 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.
PMID: 30414054DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof.dr.
Study Record Dates
First Submitted
December 15, 2016
First Posted
December 23, 2016
Study Start
January 1, 2017
Primary Completion
June 26, 2017
Study Completion
September 1, 2017
Last Updated
May 18, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share