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Clinical Trials/NCT04283851
NCT04283851
Completed
N/A

Dynamic Parameters in Evaluation of Fluid Resposiveness in Cardiac Surgery Patients in the Early Postoperative Period

Charles University, Czech Republic1 site in 1 country50 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypovolemia
Sponsor
Charles University, Czech Republic
Enrollment
50
Locations
1
Primary Endpoint
Prediction of fluid responsiveness
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Intravenous infusion of fluids in patients after surgery is a very important part of treatment. However, administering too much or too little fluid can lengthen the stay in the intensive care unit or even harm the patient. Therefore, fluid therapy should be tailored to the individual needs of each patient. Several methods are available to assess which patients will likely benefit from fluid administration. However, each of these methods is useful only under certain conditions. The study aims to explore some less-known, yet promising tests which could make adequate fluid administration more precise and easier to achieve.

Detailed Description

Adequate fluid therapy is one of the most important variables influencing patient outcome in intensive care. Fluid therapy should be tailored to the individual needs of each patient. Static parameters of preload have proved to be of little predictive value, therefore dynamic parameters are preferred for prediction of fluid responsiveness. Ideally, the cardiac output increases by 10% after a standardised fluid challenge. There are several methods already available to differentiate fluid-responsive from fluid-unresponsive patients, most notably the passive leg-raise. However, each of these methods has its own set of indications and contraindications. Also, a combination of tests could guide clinician´s decision in cases where the results of a single test are not entirely conclusive. Therefore, it would be desirable to add some less-known methods for prediction of fluid responsiveness, like the end-expiratory and end-inspiratory occlusion tests along with the assessment of diastolic properties of cardiac ventricles. The aims of the study are: * to determine the optimal increase in LVOT VTi to reliably predict fluid responsiveness * to explore the accuracy of echocardiographic LVOT VTi evaluation during end-expiratory and end-inspiratory occlusion tests and their combination * to assess the difference in echocardiographic properties of cardiac ventricles in fluid-responsive and fluid-unresponsive patients * to compare the prediction based on echocardiography with the response to a standardised fluid challenge * to assess the feasibility and practicality of echocardiographic monitoring in anesthetised cardiac surgery patients in intensive care

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Charles University, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Martin Balik

Principal Investigator: Jan Horejsek, General University Hospital in Prague

Charles University, Czech Republic

Eligibility Criteria

Inclusion Criteria

  • patients after elective coronary artery bypass grafting
  • hypovolemia indicated for volumotherapy by the attending physician based on clinical and laboratory signs (ScvO2 under 65 % with serum lactate above 2 mmol/l, increase of vasopressoric support with CVP under 5 mmHg)
  • intubated and ventilated patients
  • sedation without spontaneous breathing activity
  • no pulmonary pathology on X-ray after surgery
  • normal systolic and diastolic function of both ventricles (left ventricular ejection fraction above 50 %, TAPSE of the right ventricle above 20 mm, FAC of the right ventricle above 30 %)
  • informed consent signed before surgery

Exclusion Criteria

  • aggresive artificial ventilation (PEEP above 10 cmH2O, Pmax above 30 cm H2O)
  • ARDS, pneumothorax, fluidothorax
  • hemodynamically significant valvular disease
  • atrial fibrillation or other arrhythmia with irregular heartbeat
  • intraabdominal hypertension with pressures above 15 mmHg
  • open thorax
  • bad echogenicity

Outcomes

Primary Outcomes

Prediction of fluid responsiveness

Time Frame: The first hour after surgery

fluid responsiveness is defined as a 10 % increase in cardiac output after a standardised fluid challenge; the prediction will be made based on the diastolic properties of both cardiac ventricles and the changes in LVOT VTi during end-expiratory and end-inspiratory occlusion tests

Secondary Outcomes

  • Oxygenation response(The first hour after surgery)
  • Cardiac output monitoring with Vigileo FloTrac(The first hour after surgery)
  • Echocardiographic evaluation of LVOT VTi and its changes(The first hour after surgery)
  • Heart rate response(The first hour after surgery)
  • Arterial pressure response(The first hour after surgery)
  • Central venous pressure response(The first hour after surgery)

Study Sites (1)

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