Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
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ClinicalTrials.gov Identifier: NCT02561247 |
Recruitment Status :
Terminated
First Posted : September 28, 2015
Results First Posted : June 16, 2021
Last Update Posted : June 25, 2021
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Condition or disease | Intervention/treatment | Phase |
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Acute Kidney Injury in Pediatric Patients | Device: Prismaflex HF20 CRRT Filter Device: Prismaflex® System 7.10 and 7.20 | Not Applicable |
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 |

Arm | Intervention/treatment |
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Experimental: Prismaflex HF20 CRRT
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.
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Device: Prismaflex HF20 CRRT Filter Device: Prismaflex® System 7.10 and 7.20 |
- Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT [ Time Frame: 24 hours from CRRT initiation ]Blood Urea Nitrogen (BUN)
- Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT [ Time Frame: 24 hours from CRRT initiation ]
- Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT [ Time Frame: 24 hours from CRRT initiation ]
- HF20 Set Filter Survival Time [ Time Frame: 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.
- Number of Participants Experiencing at Least One 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
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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561247
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 |
Study Director: | Baxter Study Director | Baxter Healthcare Corporation |
Documents provided by Baxter Healthcare Corporation:
Responsible Party: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT02561247 |
Other Study ID Numbers: |
Gambro 1463 |
First Posted: | September 28, 2015 Key Record Dates |
Results First Posted: | June 16, 2021 |
Last Update Posted: | June 25, 2021 |
Last Verified: | June 2021 |
Acute Kidney Injury Continuous Renal Replacement Therapy Blood Urea Nitrogen (BUN) Prismaflex Pediatric |
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |