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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
Results First Posted : June 16, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Prismaflex HF20 CRRT
Patients included in this arm will be treated for a minimum period of 20 of the first 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


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT [ Time Frame: 24 hours from CRRT initiation ]
    Blood Urea Nitrogen (BUN)


Secondary Outcome Measures :
  1. Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT [ Time Frame: 24 hours from CRRT initiation ]
  2. Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT [ Time Frame: 24 hours from CRRT initiation ]
  3. HF20 Set Filter Survival Time [ Time Frame: Up to 72 Hours after Initiation ]
    Filters that were replaced any time CRRT was stopped for reasons other than the failure to mediate the two alarms specified were censored at their current duration of usage (filter clotted and TMP excessive). Only filters that were replaced due to the two alarms were considered events for this survival analysis. A total of 34 filters were used in the study and 22 filters were censored, leaving data from only 12 filters to complete the survival estimate. Due to the small amount of filter data available, only the 25th percentile survival estimate was used since the 50th and 75th percentiles were not reached. Filter life of filters were analyzed using a Kaplan Meier survival curve with quartile survival times after the start of CRRT.


Other Outcome Measures:
  1. Number of Participants Experiencing at Least One 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

    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


Eligibility Criteria
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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 AKI defined as either 1) AKI by the Kidney Disease Improving Global Outcomes (KDIGO) Acute Kidney Injury Guideline serum creatinine criteria, which is a >50% rise in serum creatinine over baseline or a 0.3 mg/dL SCr rise in 48 hours OR 2) as AKI by the Pediatric modified Risk, Injury, Failure, Loss, End-Stage Renal Disease (pRIFLE) criteria which is a 25% reduction in estimated creatinine clearance,16 OR 3) a serum creatinine >1.2 mg/dL. OR Patients with severe fluid overload, defined as a >10% fluid accumulation relative to the ICU admission.
  3. Patients who have received RRT previously can be included in the study if >24 hours have elapsed since their previous RRT treatment.
  4. Provide written informed consent from one or both parents, as required by the local IRB or legal guardians, 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.
Contacts and Locations
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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
  Study Documents (Full-Text)

Documents provided by Baxter Healthcare Corporation:
Study Protocol  [PDF] December 6, 2017
Statistical Analysis Plan  [PDF] May 30, 2018

More Information
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02561247    
Other Study ID Numbers: Gambro 1463
First Posted: September 28, 2015    Key Record Dates
Results First Posted: June 16, 2021
Last Update Posted: June 25, 2021
Last Verified: June 2021
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