Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02561247|
Recruitment Status : Terminated
First Posted : September 28, 2015
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury in Pediatric Patients||Device: Prismaflex HF20 CRRT Filter Device: Prismaflex® System 7.10 and 7.20||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Prismaflex HF20 Set and Prismaflex® System 7.10 for Acute CRRT in Children|
|Actual Study Start Date :||November 10, 2015|
|Actual Primary Completion Date :||April 6, 2018|
|Actual Study Completion Date :||April 6, 2018|
Experimental: Prismaflex HF20 CRRT
Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set with BUN, creatinine and bicarbonate being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Device: Prismaflex HF20 CRRT Filter
Device: Prismaflex® System 7.10 and 7.20
- Blood Urea Nitrogen [ Time Frame: 24 hours from CRRT initiation ]The primary endpoint is the change from baseline in BUN measured at 24 hours following initiation of CRRT.
- Creatinine [ Time Frame: 24 hours from CRRT initiation ]The change from baseline creatinine measured at 24 hours following initiation of CRRT.
- Bicarbonate [ Time Frame: 24 hours from CRRT initiation ]The change from baseline bicarbonate measured at 24 hours following initiation of CRRT.
- Prismaflex alarms related to fluid balance and extracorpeal life [ Time Frame: Up to 72 hours from CRRT initiation ]
The end of the extracorporeal circuit life will be defined by the occurrence of one or both of the following Prismaflex ® System alarms, after which CRRT will be terminated and the extracorporeal circuit replaced:
- "Warning: Filter is Clotted", and/or
- "Caution: TMP (Trans Membrane Pressure) Excessive" At 72 hours from the initiation of HF20 study CRRT, the site may follow applicable institutional practices if additional CRRT is required.
Alarms from Prismaflex ® System 7.10 related to fluid balance will be noted and recorded for the following alarms:
- "Caution: Flow Problem"
- "Caution: Gain Limit Reached"
- "Caution: Loss Limit Reached"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561247
|United States, California|
|Lucile Packard Children's Hospital Stanford|
|Stanford, California, United States, 94305|
|United States, Iowa|
|University of Iowa Children's Hospital|
|Iowa City, Iowa, United States, 52242|
|United States, Michigan|
|Helen DeVos Children's Hospital|
|Grand Rapids, Michigan, United States, 49503|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Texas|
|Children's Medical Center of Dallas|
|Dallas, Texas, United States, 75235|
|United States, Washington|
|Seattle Children's Hospital - Divison of Nephrology|
|Seattle, Washington, United States, 98105|
|Study Director:||Baxter Study Director||Baxter Healthcare Corporation|