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Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children

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ClinicalTrials.gov Identifier: NCT02561247
Recruitment Status : Terminated
First Posted : September 28, 2015
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:
The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury (AKI) in pediatric patients by reducing blood urea nitrogen (BUN).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Creatinine [ Time Frame: 24 hours from CRRT initiation ]
    The change from baseline creatinine measured at 24 hours following initiation of CRRT.

  2. Bicarbonate [ Time Frame: 24 hours from CRRT initiation ]
    The change from baseline bicarbonate measured at 24 hours following initiation of CRRT.


Other Outcome Measures:
  1. 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"



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a hospital admission body weight ≥8 and <20 kg (ie, ≥17.6 and <44.09 lbs).
  2. Patients with acute kidney injury (AKI) defined as either 1) Acute Kidney Injury by the Kidney Disease Improving Global Outcomes (KDIGO) Acute Kidney Injury Guideline serum creatinine (SC) criteria, which is a >50% rise in serum creatinine over baseline or a 0.3 mg/dL SC rise in 48 hours, OR 2) as Acute Kidney Injury as defined by the pediatric modified Risk, Injury, Failure, Loss, End-Stage Renal Disease (pRIFLE) criteria which is a 25% reduction in estimated creatinine clearance, OR 3) a serum creatinine ≥1.2 mg/dL.
  3. Patients who have received renal replacement therapy (RRT) previously can be included in the study if >72 hours have elapsed since previous RRT provision.
  4. Provide written informed consent from one or both parents as required by the local IRB or a legal guardian unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child per 21 CFR Part 50.55(e).

Exclusion Criteria:

  1. Patients a) weighing 8.0-20.0 kg with a hemoglobin of <7.0 g/dL, b) weighing 8.0-12.0 kg with a hemoglobin of <8.0 g/dL (unless blood prime used), and c) weighing 12.1-20.0 kg with a hemoglobin of <7.5 g/dL (unless blood prime used).
  2. Children who are wards of the state.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Study Director: Baxter Study Director Baxter Healthcare Corporation

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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02561247     History of Changes
Other Study ID Numbers: Gambro 1463
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Keywords provided by Baxter Healthcare Corporation:
Acute Kidney Injury
Continuous Renal Replacement Therapy
Blood Urea Nitrogen (BUN)
Prismaflex
Pediatric
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases