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NCT Number: NCT04283851

Dynamic Parameters in Evaluation of Fluid Responsiveness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University

Prague, 120 00, Czechia

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

testing functional haemodynamic parameters for preload assessment

Diagnostic Test

dynamic testing of preload responsivity plus echocardiography

Primary outcomes

  1. 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

  1. Echocardiographic evaluation of LVOT VTi and its changes

    Time frame: The first hour after surgery

    TTE measurement of LVOT VTi and its changes during end-expiratory, end-inspiratory occlusion tests and after a standardised fluid challenge of a colloid

  2. Cardiac output monitoring with Vigileo FloTrac

    Time frame: The first hour after surgery

    continous measurement of cardiac output with Vigileo FloTrac and its correlation with the changes of echocardiographic parameters

  3. Arterial pressure response

    Time frame: The first hour after surgery

    invasive arterial blood pressure

  4. Heart rate response

    Time frame: The first hour after surgery

    heart rate

  5. Oxygenation response

    Time frame: The first hour after surgery

    pulse oxymetry

  6. Central venous pressure response

    Time frame: The first hour after surgery

    central venous pressure

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Feb 25, 2020
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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