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

Completed

• Conditions: Coronary Artery Disease; Fluid Overload; Hypovolemia
• Interventions: Procedure: Fluids

• Registration Number: NCT02903316
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Study Start: 2016-10
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluid Therapy	Fluids	Systematisation of fluids during CABG surgery

Primary Outcome Measures

Name	Time	Method
Cardiac output changes	At 5 minutes	From initiation of fluid infusion
Systolic arterial pressure changes	10 minutes prior to fluid infusion	In relation to extra systoles

Secondary Outcome Measures

Name	Time	Method
Arterial waveform changes	10 seconds	From initiation of the mini fluid challenge (part of the compiled fluid challenge)

Trial Locations

Locations (1)

Department of Anesthesia and Intensive Care Medicine, Cardiothoracic Anesthesia, Head & Heart Centre, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark