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QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QUELIMMUNE Surveillance Registry Participants | All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUELIMMUNE (SCD-PED) | Device | QUELIMMUNE device used as part of clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner | 28 days or through hospital discharge, whichever is sooner |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients (weight ≥10kg and age ≤22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT), per device Instructions For Use. All patients who receive treatment with QUELIMMUNE as part of their therapy are included in this registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Zidan, MD | Contact | 844-427-8100 | mzidan@seastarmed.com | |
| Kevin K Chung, MD | Contact | 844-427-8100 | kchung@seastarmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States | |
| Lucile Packard Children's Hospital Stanford |
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| Recruiting |
| Palo Alto |
| California |
| 94304 |
| United States |
| UCSF Benioff Children's | Recruiting | San Francisco | California | 94618 | United States |
| HealthONE HCA Rocky Mountain Children's Hospital | Recruiting | Denver | Colorado | 80205 | United States |
| Children's Hospital of Atlanta - Arthur M. Blank | Recruiting | Atlanta | Georgia | 30329 | United States |
| Children's Hospital of Atlanta - Scottish Rite | Recruiting | Atlanta | Georgia | 30342 | United States |
| Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
| CS Mott Children's Hospital | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic Children's Hospital | Recruiting | Cleveland | Ohio | 44106 | United States |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Monroe Carrell Jr Children's Hospital at Vanderbilt | Recruiting | Nashville | Tennessee | 37232 | United States |
| Children's Medical Center Dallas | Recruiting | Dallas | Texas | 75235 | United States |
| Cook Children's Hospital | Recruiting | Fort Worth | Texas | 76104 | United States |
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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