Dynamic Parameters in Evaluation of Fluid Responsiveness

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Charles University, Czech Republic
Updated on 16 February 2024
fluid therapy
ejection fraction
serum lactate
coronary artery bypass graft
coronary artery bypass
tapse
pulmonary pathology

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.

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 clinicians 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

Details
Condition Surgery, Hypotension, Vascular Diseases, Vascular Diseases, Surgical aspects, Hypovolemia, Surgery
Age 18years - 100years
Treatment testing functional haemodynamic parameters for preload assessment
Clinical Study IdentifierNCT04283851
SponsorCharles University, Czech Republic
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.