Clinical trial NCT02903316: Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Coronary Artery Disease
Fluid Overload
Keywords: Fluid responsiveness
Perioperative
Extra systoles
Coronary artery bypass
Systolic arterial pressure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2016-09-16
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for elective on pump CABG surgery at Aarhus University Hospital, SKS.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac output changes
timeFrame: At 5 minutes
measure: Systolic arterial pressure changes
timeFrame: 10 minutes prior to fluid infusion
Secondary outcomes:
measure: Arterial waveform changes
timeFrame: 10 seconds
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Anesthesia and Intensive Care Medicine, Cardiothoracic Anesthesia, Head & Heart Centre, Aarhus University Hospital
Study officials:
References:
citation: Berg JM, Nielsen DV, Abromaitiene V, Hjornet NE, Vistisen ST. Changes in arterial blood pressure characteristics following an extrasystolic beat or a fast 50 ml fluid challenge do not predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2022 Jun;36(3):889-900. doi: 10.1007/s10877-021-00722-z. Epub 2021 May 26.