Initial data from COVID-19 patients suggests that one of the primary causes of death is significant endothelial injury leading to blood clotting and impaired multiorgan microvascular perfusion. The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients in vivo and assess the significance of imaging findings by correlating to clinical outcomes. This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. We will enroll and evaluate 30 patients.
The current study uses a safe, convenient bedside imaging tool called contrast-enhanced
ultrasound (CEUS) to measure the extent of microvascular perfusion impairment in the heart,
kidneys and/or brain of COVID-19 pediatric patients and, as exploratory analysis, to assess
the significance of imaging findings by correlating to clinical outcomes.
Sulfur hexafluoride lipid-type A microspheres (LumasonTM, Bracco Inc) is an FDA-approved
ultrasound contrast agent. Contrast-enhanced ultrasound scan with a duration of approximately
15 minutes will be performed when a COVID-19 diagnosis has been made (or is highly suspected)
according to established clinical procedures. One CEUS will be performed per patient, with up
to 2 intravenous injections of the contrast agent. The dosing plan will be weight-adjusted,
based on a dose of 0.03 mL/kg (with a maximum dose of 2.4 mL per injection). Organ perfusion
will be evaluated in the heart, kidneys, and/or brain. Clinical outcomes during hospital stay
will be collected for correlation to CEUS-based measures.
Drug: Sulfur hexafluoride lipid-type A microspheres
Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed to evaluate for dynamic bowel perfusion and several 2-minute cine clips as well as static images will be acquired during the exam.
Inclusion Criteria:
1. Patient (male/female) hospitalized at CHOP.
2. Patient 17 years of age or younger.
3. Diagnosis of COVID-19 or high clinical suspicion for COVID-19 despite negative tests
(according to the definition of probable case by the ECDC).
4. Patients have evidence of cardiovascular compromise, myocardial injury, acute kidney
injury and/or new-onset neurological symptoms.
5. Parental/guardian permission (informed consent)
Exclusion Criteria:
1. Medical history of Lumason hypersensitivity
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Investigator: Misun Hwang, MD
Contact: 267-425-7110
hwangm@chop.edu
Misun Hwang, MD
267-425-7129
hwangm@chop.edu