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

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

Study Description

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

• 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

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

Outcome Measures

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"

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: Baxter Study Director; Baxter Healthcare Corporation

More Information

• Responsible Party: Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT02561247
• Other Study ID Numbers: Gambro 1463
• First Posted: September 28, 2015
• 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:

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases; Urologic Diseases