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Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles

Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles and Investigation of a Novel Mini Fluid Challenge Ability to Predict Fluid Responsiveness

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02903316
Enrollment
95
Registered
2016-09-16
Start date
2016-10-31
Completion date
2017-10-31
Last updated
2017-10-27

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

Conditions

Hypovolemia, Coronary Artery Disease, Fluid Overload

Keywords

Fluid responsiveness, Perioperative, Extra systoles, Coronary artery bypass, Systolic arterial pressure

Brief summary

The purpose of this study is to determine if extra systoles can be used to predict fluid responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft (CABG) surgery. As an additional study we will investigate the ability of a mini fluid challenge to predict response of a larger volume of fluid.

Detailed description

From induction of anaesthesia to cardioplegia we will serve two fluid challenges. Before and after each challenge we will collect hemodynamic data and use this to asses our two hypotheses. Fluid responsiveness (the outcome to predict) will be defined as a 15% increase in stroke volume(SV) from immediately before fluid infusion is initiated (baseline) to after the full fluid infusion. Stroke volume is derived from the gold-standard pulmonary artery catheter measurement of cardiac output(CO), which is standard monitoring for these patients (SV = CO/heart rate). From subsequent offline analysis of the extracted curve data we will investigate if post-ectopic characteristics from identified extra systoles during the baseline period can predict fluid responsiveness (i.e. the SV change). This analysis addresses the primary hypothesis. Also, we will analyse the arterial waveform related to the mini fluid challenge for morphologic changes (comparing heart beats before the infusion with heart beats during the infusion) and see if such transient changes, e.g. in systolic blood pressure, are able to predict fluid responsiveness. This analysis addresses the secondary hypothesis.

Interventions

PROCEDUREFluids

Sponsors

Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Predominant sinus rhythm (No atrial fibrillation, trigemini, 2nd and 3rd degree atrioventricular block also if pacing is present etc.)

Exclusion criteria

* Ejection fraction \< 35% (Safety limit minimising risk of fluid overload) * Haemodialysis (safety precaution for patients with end-stage kidney failure) * Pregnancy * Mentally retarded (due to lack of capability to sign an informed consent)

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output changesAt 5 minutesFrom initiation of fluid infusion
Systolic arterial pressure changes10 minutes prior to fluid infusionIn relation to extra systoles

Secondary

MeasureTime frameDescription
Arterial waveform changes10 secondsFrom initiation of the mini fluid challenge (part of the compiled fluid challenge)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026