Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869787
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2021-04-28
Brief Title:
A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
A Multi-Center Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device SCD for the Treatment of Immunomodulatory Dysregulation Due to Pediatric Acute Kidney Injury AKI
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The device manufacturer has received a HDE for this population from the FDA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCD PED-02
Brief Summary:
The SCD PED-02 trial is examining the safety and efficacy of the Selective Cytopheretic Device SCD in treating pediatric acute kidney injury AKI AKI promotes a systemic inflammatory response syndrome SIRS which results in systemic microvascular damage and if severe multi-organ dysfunction Activated circulating leukocytes play a central role in this process The SCD is a synthetic membrane with the ability to bind activated leukocytes and when used in a continuous renal replacement therapy CRRT extracorporeal circuit in the presence of regional citrate anticoagulation modulates inflammation The SCD PED-02 study will test the primary hypothesis that up to ten sequential 24-hour SCD treatments in pediatric patients with AKI will be completed safely and improve survival compared to historical controls who received CRRT alone
Detailed Description:
The SCD PED-02 trial is examining the safety and efficacy of the Selective Cytopheretic Device SCD in treating pediatric acute kidney injury AKI Importantly acute kidney injury is a highly lethal condition in critically ill patients Despite improvements in acute medical care and advances in dialysis therapies the mortality rate during the past four decades of this condition has not improved Critically ill patients with AKI in hospital ICU settings have mortality rates of approximately 50 including pediatric patients AKI promotes a systemic inflammatory response syndrome SIRS which results in systemic microvascular damage and if severe multi-organ dysfunction Activated circulating leukocytes play a central role in this process Leukocytes especially neutrophils are major contributors to the pathogenesis and progression of many inflammatory disorders including SIRS sepsis ischemia reperfusion injury and acute respiratory distress syndrome ARDS Many therapeutic approaches are under investigation to limit the activation and tissue accumulation of leukocytes at sites of inflammation to minimize tissue destruction and disease progression
The SCD is comprised of tubing connectors and a synthetic membrane cartridge The device is connected in series to a commercially available Continuous Renal Replacement Therapy CRRT device Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space ECS of the SCD Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits The SCD is a synthetic membrane with the ability to bind activated leukocytes and when used in a continuous renal replacement therapy CRRT extracorporeal circuit in the presence of regional citrate anticoagulation modulates inflammation
The SCD PED-02 study will test the primary hypothesis that up to ten sequential 24-hour SCD treatments in pediatric patients with AKI will be completed safely and improve survival compared to historical controls who received CRRT alone
The SCD is comprised of tubing connectors and a synthetic membrane cartridge The device is connected in series to a commercially available Continuous Renal Replacement Therapy CRRT device Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space ECS of the SCD Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits The SCD is a synthetic membrane with the ability to bind activated leukocytes and when used in a continuous renal replacement therapy CRRT extracorporeal circuit in the presence of regional citrate anticoagulation modulates inflammation
The SCD PED-02 study will test the primary hypothesis that up to ten sequential 24-hour SCD treatments in pediatric patients with AKI will be completed safely and improve survival compared to historical controls who received CRRT alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None