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FLuid Responsiveness Prediction Using EXtra Systoles

FLuid Responsiveness Prediction Using EXtra Systoles

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03002129
Enrollment
60
Registered
2016-12-23
Start date
2017-01-31
Completion date
2017-09-30
Last updated
2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Graft

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

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

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
fluid challenge response in stroke volumeduring operationTo 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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026