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

Stopped early · Not applicable

Conditions studied: Acute Kidney Injury in Pediatric Patients

In brief

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).

Key facts

Study ID

NCT02561247

Run by

Vantive Health LLC

People needed

23

Starts

2015-11-10

Expected to finish

2018-04-06

Last updated by the study team

2025-07-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a hospital admission body weight ≥8 and <20 kg (ie, ≥17.6 and <44.09 lbs).
• 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.
• Patients who have received RRT previously can be included in the study if >24 hours have elapsed since their previous RRT treatment.
• 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).

You may not qualify if…

• 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).
• Children who are wards of the state.

Where it is running

• Lucile Packard Children's Hospital Stanford — Stanford, California, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Seattle Children's Hospital - Divison of Nephrology — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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