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

Not Applicable

Terminated

• Conditions: Acute Kidney Injury in Pediatric Patients
• Interventions: Device: Prismaflex HF20 CRRT Filter; Device: Prismaflex® System 7.10 and 7.20

• Registration Number: NCT02561247
• Lead Sponsor: Vantive Health LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-28
• Study Start: 2015-11-10
• Primary Completion: 2018-04-06
• Study Completion: 2018-04-06
• Disposition First Submitted: 2019-05-24
• Disposition First Submitted QC: 2019-05-24
• Disposition First Posted: 2019-06-03
• Results First Submitted: 2021-05-21
• Results First Submitted QC: 2021-05-21
• Results First Posted: 2021-06-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prismaflex HF20 CRRT	Prismaflex HF20 CRRT Filter	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.
Prismaflex HF20 CRRT	Prismaflex® System 7.10 and 7.20	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.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT	24 hours from CRRT initiation	Blood Urea Nitrogen (BUN)

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT	24 hours from CRRT initiation
HF20 Set Filter Survival Time	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.
Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT	24 hours from CRRT initiation

Trial Locations

Locations (6)

University of Iowa Children's Hospital; 🇺🇸 Iowa City, Iowa, United States

Lucile Packard Children's Hospital Stanford; 🇺🇸 Stanford, California, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Helen DeVos Children's Hospital; 🇺🇸 Grand Rapids, Michigan, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Seattle Children's Hospital - Divison of Nephrology; 🇺🇸 Seattle, Washington, United States