Status:
COMPLETED
Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Pediatric Kidney Disease
Acute Kidney Injury
Eligibility:
All Genders
Brief Summary
Historically, innovations for acute kidney injury (AKI) and continuous renal replacement therapy (CRRT) have centered around an adult population. However, research has shown that over 10% of pediatric...
Eligibility Criteria
Inclusion
- Receiving or plan to receive CRRT with the HF20™ filter as standard of care
- Acute kidney injury (AKI) or fluid overload as defined as one of the two below:
- AKI defined as Kidney Disease Improving Global Outcomes (KDIGO) Stage 1 or higher by either:
- Serum creatinine criteria (0.3 mg/dL increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days) or
- Urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours)
- Severe fluid overload defined as greater than 10 percent fluid accumulation based on ICU admission weight
Exclusion
- Weight less than 8 kilograms
- Weight more than 20 kilograms
- Patient not expected to survive more than 48 hours
- Received renal replacement therapy in the previous 5 days
Key Trial Info
Start Date :
January 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04836026
Start Date
January 27 2021
End Date
November 30 2023
Last Update
December 21 2023
Active Locations (3)
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1
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Seattle Children's
Seattle, Washington, United States, 98105