Myocardial Contrast Echocardiography in Septic Patients

NCT04397640 | Unknown DMC

• 1 other identifier: BUN 3202042835
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Microcirculation

Keywords

Sepsis; Septic cardiomyopathy; Contrast echocardiography; Sulphur hexafluoride microbubbles contrast Sonovue

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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

  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

  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

  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.

  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.

  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.

  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.

  Comparison to baseline (24 hours after ICU admission) and then once daily during the study period

Study Arms (1)

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.

Diagnostic Test: Sonovue

Interventions

Sonovue DIAGNOSTIC_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.

Sonovue

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

Related Publications (4)

• 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.

  PMID: 28950366 BACKGROUND

• Orde S, McLean A. Bedside myocardial perfusion assessment with contrast echocardiography. Crit Care. 2016 Mar 15;20:58. doi: 10.1186/s13054-016-1215-7.

  PMID: 26976127 BACKGROUND

• Lang 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.

  PMID: 16458610 BACKGROUND

• Beesley 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.

  PMID: 29227368 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Duc Nam Nguyen, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duc Nam Nguyen, MD, PhD

CONTACT

003224775178; namduc.nguyen@uzbrussel.be

Godelieve Opdenacker, Study nurse

CONTACT

003224775117; godelieve.opdenacker@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Cohort study in a single center

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 21, 2020
• Study Start: January 31, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)