Covid19, Multisystem Inflammatory Syndrome in Children (MIS-C)
Conditions
Keywords
Ultrasound, Contrast-enhanced ultrasound
Brief summary
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. The investigators plan to enroll and evaluate 30 patients.
Detailed description
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.
Interventions
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.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Patient (male/female) hospitalized at the Children's Hospital of Philadelphia (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 European Centre for Disease Prevention and Control). 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain | 15 minutes. | Assess microvascular perfusion of the heart, kidneys and/or brain using CEUS in patients with confirmed or probable diagnosis of COVID-19. A sufficient diagnostic quality to analyze the ultrasound examination was accomplished in three out of four patients. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Population 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Study Population |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 7.5 years STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hospital stay | 7 Days |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain
Assess microvascular perfusion of the heart, kidneys and/or brain using CEUS in patients with confirmed or probable diagnosis of COVID-19. A sufficient diagnostic quality to analyze the ultrasound examination was accomplished in three out of four patients.
Time frame: 15 minutes.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contrast-enhanced Ultrasonography | Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain | No microvascular perfusion defect observed | 2 Participants |
| Contrast-enhanced Ultrasonography | Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain | Microvascular perfusion defect observed (Left ventricular wall and kidney) | 1 Participants |