Myocardial Contrast Echocardiography in Septic Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Universitair Ziekenhuis Brussel
Updated on 25 January 2021
resuscitation
organ failure
shock
lactate level
vasoconstrictors
dysregulated host response

Summary

Myocardial microcirculatory alterations may be involved in the pathogenesis of acute cardiac dysfunction or septic cardiomyopathy in septic patients. The investigators study the cardiac function (systolic and diastolic) with two-dimensional echocardiography (TTE), and the myocardial microcirculation with contrast echocardiography (MCE) and sulphur hexafluoride microbubbles Sonovue injection in ICU septic patients.

Description

Using the IE33 device (Philips Medical Systems, the Netherlands), two-dimensional and myocardial contrast echocardiography (TTE and MCE) are performed following the recommendations of the American Heart Association and the European Society of Cardiology (2006), and the European Association of Cardiovascular Imaging (2017). TTE and MCE are performed at the same time in the first 24 hours after ICU admission, at 48-72 hours, at 5-10 days after withdrawal of vasopressors and inotropes.

First, TTE evaluates from the apical and parasternal views:

  • The Wall motion score index (WMSI) of 16 myocardial segments of the left ventricle (LV).
  • The diastolic function using pulsed-wave doppler and pulsed tissue doppler at the mitral valve.
  • Quantify valvular insufficiency
  • Estimation of cardiac output (L/ minute).
  • Evaluation of the right ventricle (RV) dimension and its the longitudinal contractility by the Tricuspid annular plane systolic excursion (TAPSE) with pulsed tissue doppler.
  • Left atrial volume (ml).
  • Systolic pulmonary pressure and pulmonary resistance with both continuous and pulsed-wave doppler at the tricuspid valve and the pulmonary outflow tract, respectively.

Second, MCE is performed if:

  • Systolic blood pressure < 200 mmHg or > 90 mmHg,
  • Heart rate < 130 or > 50 beats/minute
  • Peripheral pulse oxygen saturation > 90%
  • Arterial oxygen partial pressure (PaO2) 70 mmHg
  • Arterial pH 7.25.

Administration of contrast agent Sonovue requires an infusion pump (Vueject, Bracco, Milan, Italy), which provides constant agitation to maintain the homogeneity distribution of Sonovue. Injection of Sonovue allows an enhancement of LV endocardial border and regional function to evaluate:

  • LV end-diastolic and end-systolic volumes (ml) and ejection fraction (%) using the Simpson method.
  • The WMSI of the left ventricle (LV) after Sonovue injection.

After optimization of transthoracic cardiac views, the mechanical index will settle between 0.1-0.2 and keeps unchanged during the procedure. Sonovue vial of 5 ml will dilute in in 10 ml saline solution and administrate at 0.7-1.5 ml/min. Using acquire flash-replenishment sequences during15 cardiac cycles of the apical 4-2-3 chamber views with the flash delivered after the second cardiac cycle. This technique destroys the microbubbles presents in the myocardium and allows replenishment with new microbubbles concentrations.

The volume of blood within the entire coronary circulation at rest in diastole is predominantly resided within the capillaries. The myocardial signal intensity emanating from the contrast agent reflects the concentration of microbubbles within the myocardium. It takes 5 seconds for complete replenishment of the myocardium. Any decrease in myocardial blood flow prolongs replenishment time in proportion to its reduction.

Immediately after microbubble infusion is started, all real-time MCE procedures are recorded for one minute and stored as DICOM (Digital Image Communications in Medicine) images. Offline analysis uses a specific quantification software named QLAB10 (Philips Medical Systems, the Netherlands) to convert myocardial perfusion images into time-intensity curves (TIC) corresponding to different regions of interest (ROI) of the 16 myocardial segments.

Four variables are analyzed from these TIC curves to evaluate qualitatively the myocardial

microcirculation
  • peak intensity (PI) in decibel (dB).
  • time to peak intensity in seconds (TTP).
  • mean transit time in seconds (MTT).
  • Area under the curve in dB/seconds (AUC).

The cardiac biomarkers including High sensivity cardiac troponin I for myocardial injury and N-terminal pro-brain natriuretic peptide (NT-proBNP) for heart failure are measured once daily in routine clinical practice.

Details
Condition Septicemia, Sepsis and Septicemia, Microcirculation, Sepsis and Septicemia, systemic infection, systemic infections, sepsis, sepsis syndrome
Treatment SonoVue
Clinical Study IdentifierNCT04397640
SponsorUniversitair Ziekenhuis Brussel
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Sepsis: a life-threatening organ dysfunction (defined as an acute change in total Sequential Organ Failure Assessment (SOFA) score > 2 points consequent to infection) caused by a dysregulated host response to infection
Sepsis shock : a subset of sepsis with persisting hypotension requiring vasopressors to maintain the mean arterial pressure > 65 mmHg and having a serum lactate level > 2 mmol/L after fluid resuscitation

Exclusion Criteria

Non-survivors in the first 24 hours from sepsis
Sepsis post-acute cardiac arrest
Pregnancy
Younger than 18 years old
Acute Respiratory Distress Syndrome (ARDS) with the ratio of arterial oxygen partial pressure (mmHg) to fractional inspired oxygen (PaO2/ FiO2) < 200)
Advanced malignancy
Untreated and unstable acute coronary syndrome
History of myocardial infarction with severe left ventricular dysfunction. (Ejection fraction < 20 %)
Inoperable valvular and coronary disease
Significant right-left cardiac shunt
Untreated congenital heart disease
Severe systolic pulmonary hypertension > 80 mmHg
Insufficient echogenicity
Prior anaphylaxis reaction to the Sonovue microbubbles
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

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

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note