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Dynamic Parameters in Evaluation of Fluid Responsiveness

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04283851
Enrollment
50
Registered
2020-02-25
Start date
2020-02-01
Completion date
2022-07-01
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Hypovolemia, Surgery

Keywords

fluid responsiveness, fluid administration, volume expansion, end-expiratory occlusion test, end-inspiratory occlusion test, diastolic parameters of cardiac ventricles, echocardiography, heart-lung interactions

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

Interventions

DIAGNOSTIC_TESTtesting functional haemodynamic parameters for preload assessment

dynamic testing of preload responsivity plus echocardiography

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Prediction of fluid responsivenessThe first hour after surgeryfluid 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

MeasureTime frameDescription
Cardiac output monitoring with Vigileo FloTracThe first hour after surgerycontinous measurement of cardiac output with Vigileo FloTrac and its correlation with the changes of echocardiographic parameters
Arterial pressure responseThe first hour after surgeryinvasive arterial blood pressure
Echocardiographic evaluation of LVOT VTi and its changesThe first hour after surgeryTTE measurement of LVOT VTi and its changes during end-expiratory, end-inspiratory occlusion tests and after a standardised fluid challenge of a colloid
Oxygenation responseThe first hour after surgerypulse oxymetry
Central venous pressure responseThe first hour after surgerycentral venous pressure
Heart rate responseThe first hour after surgeryheart rate

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026