SepsisNCT04397640
Myocardial Contrast Echocardiography in Septic Patients
A study testing Sonovue in people with Sepsis and Microcirculation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Sepsis, Microcirculation
- What is being tested?
- Sonovue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Godelieve Opdenacker, study nurse, 003224775117, godelieve.opdenacker@uzbrussel.be
Marie-Claire Van Malderen, study nurse, 003224775117, marieclaire.vanmalderen@uzbrussel.be
About this study
Official title: Study of Myocardial Microcirculatory Alterations in Patients With Sepsis and Septic Shock Using Myocardial Contrast Echocardiography (MCE)
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.
Read the detailed 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.
- Conditions
- Sepsis, Microcirculation
- Being tested
- Sonovue
- Keywords
- Sepsis, Septic cardiomyopathy, Contrast echocardiography, Sulphur hexafluoride microbubbles contrast Sonovue
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonovueDiagnostic test
Contrast myocardial echocardiography with sulphur hexafluoride microbubbles Sonovue (Bracco, Milan, Italy) injection and using the time-intensity curves profile to evaluate the myocardial microcirculation.
| Study group | Role | What they receive |
|---|---|---|
| Sonovue | Other | ICU patients with sepsis and septic shock who are eligible for myocardial contrast echocardiography with sulphur hexafluoride microbubbles contrast Sonovue (Bracco, Milan, Italy) injection. Receives: Diagnostic Test: Sonovue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of the time to Peak intensity (TTP) from baseline (seconds).
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a prolonged time to Peak intensity over time.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Mean change of the Mean transit time (MTT) from baseline (seconds)
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a prolonged Mean transit time over time.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Mean change of the Peak intensity (PI) from baseline (seconds).
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a reduced Peak intensity over time
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Mean change of the Area under the curve (AUC) from baseline (dB/ seconds).
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a reduced Area under the curve (AUC) over time
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Mean change of the Wall motion score index (WMSI) from baseline (normal score: 32)
Quantitative evaluation of the regional contractility of 16 myocardial segments of LV using the Wall motion score index. The investigators expect a lower score than 32 in patients who develop cardiac dysfunction over time
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Mean change of the ejection fraction from baseline (%)
Quantitative evaluation of the global LV ejection fraction using the Simpson method. The investigators expect a lower ejection fraction than 50% in patients who develop cardiac dysfunction over time.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Mean change of the Tricuspid annular plane systolic excursion (TAPSE) of the right ventricle from baseline (mm)
Quantitative evaluation of the longitudinal contractility of the right ventricle by measuring the Tricuspid annular plane systolic excursion (TAPSE) with pulsed tissue doppler. The investigators expect lower values than 15 mm in patients who develop cardiac dysfunction over time.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Secondary outcomes (2)
Mean change of biomarker of cardiac injury: serum High sensitivity cardiac troponin I (micrograms/ L) from baseline.
Evaluation of the severity of myocardial injury associated with cardiac dysfunction by measuring High sensitivity cardiac troponin I. The investigators expect patients who develop cardiac dysfunction will have higher serum levels of this biomarker than those who do not over time.
Measured: Comparison to baseline (24 hours after ICU admission) and then once daily during the study period
Mean change of biomarker of heart failure: serum N-terminal pro-brain natriuretic peptide (NT-proBNP) (nanograms/ L) from baseline.
Evaluation of the degree of heart failure associated with cardiac dysfunction by measuring N-terminal pro-brain natriuretic peptide (NT-proBNP). The investigators expect patients who develop cardiac dysfunction will have higher serum levels of this biomarker than those who do not over time.
Measured: Comparison to baseline (24 hours after ICU admission) and then once daily during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start31 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study in a single center
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duc Nam Nguyen, Universitair Ziekenhuis Brussel
- Investigators
- Duc Nam Nguyen, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397640
- Sponsor's protocol ID
- BUN 3202042835
- Status last verified
- May 2020
- First submitted
- 17 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senior R, Becher H, Monaghan M, Agati L, Zamorano J, Vanoverschelde JL, Nihoyannopoulos P, Edvardsen T, Lancellotti P; EACVI Scientific Documents Committee for 2014-16 and 2016-18; EACVI Scientific Documents Committee for 2014-16 and 2016-18. Clinical practice of contrast echocardiography: recommendation by the European Association of Cardiovascular Imaging (EACVI) 2017. Eur Heart J Cardiovasc Imaging. 2017 Nov 1;18(11):1205-1205af. doi: 10.1093/ehjci/jex182.
PubMed 28950366Orde S, McLean A. Bedside myocardial perfusion assessment with contrast echocardiography. Crit Care. 2016 Mar 15;20:58. doi: 10.1186/s13054-016-1215-7.
PubMed 26976127Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise J, Solomon S, Spencer KT, St John Sutton M, Stewart W; American Society of Echocardiography's Nomenclature and Standards Committee; Task Force on Chamber Quantification; American College of Cardiology Echocardiography Committee; American Heart Association; European Association of Echocardiography, European Society of Cardiology. Recommendations for chamber quantification. Eur J Echocardiogr. 2006 Mar;7(2):79-108. doi: 10.1016/j.euje.2005.12.014. Epub 2006 Feb 2.
PubMed 16458610Beesley SJ, Weber G, Sarge T, Nikravan S, Grissom CK, Lanspa MJ, Shahul S, Brown SM. Septic Cardiomyopathy. Crit Care Med. 2018 Apr;46(4):625-634. doi: 10.1097/CCM.0000000000002851.
PubMed 29227368
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Myocardial Microcirculatory Alterations in Patients With Sepsis and Septic Shock Using Myocardial Contrast Echocardiography (MCE)
- ClinicalTrials.gov ID
- NCT04397640
- Acronym / sponsor ID
- BUN 3202042835
- Conditions
- Sepsis, Microcirculation
- Keywords
- Sepsis, Septic cardiomyopathy, Contrast echocardiography, Sulphur hexafluoride microbubbles contrast Sonovue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study in a single center
| Arm | Type | Receives |
|---|---|---|
| Sonovue | Other | Diagnostic Test: SonovueICU patients with sepsis and septic shock who are eligible for myocardial contrast echocardiography with sulphur hexafluoride microbubbles contrast Sonovue (Bracco, Milan, Italy) injection. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonovueContrast myocardial echocardiography with sulphur hexafluoride microbubbles Sonovue (Bracco, Milan, Italy) injection and using the time-intensity curves profile to evaluate the myocardial microcirculation. | Diagnostic test | Sonovue |
Primary outcome
Mean change of the time to Peak intensity (TTP) from baseline (seconds).
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a prolonged time to Peak intensity over time.
Mean change of the Mean transit time (MTT) from baseline (seconds)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a prolonged Mean transit time over time.
Mean change of the Peak intensity (PI) from baseline (seconds).
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a reduced Peak intensity over time
Mean change of the Area under the curve (AUC) from baseline (dB/ seconds).
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a reduced Area under the curve (AUC) over time
Mean change of the Wall motion score index (WMSI) from baseline (normal score: 32)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Quantitative evaluation of the regional contractility of 16 myocardial segments of LV using the Wall motion score index. The investigators expect a lower score than 32 in patients who develop cardiac dysfunction over time
Mean change of the ejection fraction from baseline (%)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Quantitative evaluation of the global LV ejection fraction using the Simpson method. The investigators expect a lower ejection fraction than 50% in patients who develop cardiac dysfunction over time.
Mean change of the Tricuspid annular plane systolic excursion (TAPSE) of the right ventricle from baseline (mm)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Quantitative evaluation of the longitudinal contractility of the right ventricle by measuring the Tricuspid annular plane systolic excursion (TAPSE) with pulsed tissue doppler. The investigators expect lower values than 15 mm in patients who develop cardiac dysfunction over time.
2 secondary outcomes
Mean change of biomarker of cardiac injury: serum High sensitivity cardiac troponin I (micrograms/ L) from baseline.
Time frame: Comparison to baseline (24 hours after ICU admission) and then once daily during the study period
Mean change of biomarker of heart failure: serum N-terminal pro-brain natriuretic peptide (NT-proBNP) (nanograms/ L) from baseline.
Time frame: Comparison to baseline (24 hours after ICU admission) and then once daily during the study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Background: PubMed 28950366Senior R, Becher H, Monaghan M, Agati L, Zamorano J, Vanoverschelde JL, Nihoyannopoulos P, Edvardsen T, Lancellotti P; EACVI Scientific Documents Committee for 2014-16 and 2016-18; EACVI Scientific Documents Committee for 2014-16 and 2016-18. Clinical practice of contrast echocardiography: recommendation by the European Association of Cardiovascular Imaging (EACVI) 2017. Eur Heart J Cardiovasc Imaging. 2017 Nov 1;18(11):1205-1205af. doi: 10.1093/ehjci/jex182.
- Background: PubMed 26976127Orde S, McLean A. Bedside myocardial perfusion assessment with contrast echocardiography. Crit Care. 2016 Mar 15;20:58. doi: 10.1186/s13054-016-1215-7.
- Background: PubMed 16458610Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise J, Solomon S, Spencer KT, St John Sutton M, Stewart W; American Society of Echocardiography's Nomenclature and Standards Committee; Task Force on Chamber Quantification; American College of Cardiology Echocardiography Committee; American Heart Association; European Association of Echocardiography, European Society of Cardiology. Recommendations for chamber quantification. Eur J Echocardiogr. 2006 Mar;7(2):79-108. doi: 10.1016/j.euje.2005.12.014. Epub 2006 Feb 2.
- Background: PubMed 29227368Beesley SJ, Weber G, Sarge T, Nikravan S, Grissom CK, Lanspa MJ, Shahul S, Brown SM. Septic Cardiomyopathy. Crit Care Med. 2018 Apr;46(4):625-634. doi: 10.1097/CCM.0000000000002851.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duc Nam Nguyen, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonovue in people with Sepsis and Microcirculation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duc Nam Nguyen, MD, PhD (003224775178, namduc.nguyen@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of the time to Peak intensity (TTP) from baseline (seconds). (time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397640, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.