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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903316
• Other study ID #: 53665
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: October 25, 2017
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: September 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Fluid Overload
• Hypovolemia
• Myocardial Ischemia

Intervention

Procedure:
• Fluids

Locations

Country	Name	City	State
Denmark	Department of Anesthesia and Intensive Care Medicine, Cardiothoracic Anesthesia, Head & Heart Centre, Aarhus University Hospital	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output changes	From initiation of fluid infusion	At 5 minutes
Primary	Systolic arterial pressure changes	In relation to extra systoles	10 minutes prior to fluid infusion
Secondary	Arterial waveform changes	From initiation of the mini fluid challenge (part of the compiled fluid challenge)	10 seconds