Clinical trial NCT02561247: Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
Official title: Clinical Evaluation of the Prismaflex HF20 Set and Prismaflex® System 7.10 for Acute CRRT in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury in Pediatric Patients
Keywords: Acute Kidney Injury
Continuous Renal Replacement Therapy
Blood Urea Nitrogen (BUN)
Prismaflex
Pediatric
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2015-09-28
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT
timeFrame: 24 hours from CRRT initiation
Secondary outcomes:
measure: Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT
timeFrame: 24 hours from CRRT initiation
measure: Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT
timeFrame: 24 hours from CRRT initiation
measure: HF20 Set Filter Survival Time
timeFrame: Up to 72 Hours after Initiation
Other outcomes:
measure: Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life
timeFrame: Up to 72 hours from CRRT initiation
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital - Divison of Nephrology
state: Washington
Study officials:
References: