TerminatedNot Applicable

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

United States23 participantsStarted 2015-11-10

Plain-language 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).

Who can participate

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT

Timeframe: 24 hours from CRRT initiation

Trial details

NCT IDNCT02561247

SponsorVantive Health LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-04-06

Results submitted2021-05-21

View on ClinicalTrials.gov More Acute Kidney Injury in Pediatric Patients trials