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Clinical Trials/NCT02903316
NCT02903316
Completed
N/A

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

University of Aarhus1 site in 1 country95 target enrollmentOctober 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypovolemia
Sponsor
University of Aarhus
Enrollment
95
Locations
1
Primary Endpoint
Cardiac output changes
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
October 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Cardiac output changes

Time Frame: At 5 minutes

From initiation of fluid infusion

Systolic arterial pressure changes

Time Frame: 10 minutes prior to fluid infusion

In relation to extra systoles

Secondary Outcomes

  • Arterial waveform changes(10 seconds)

Study Sites (1)

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