Acute Kidney Injury in Pediatric Patients Clinical Trial
Official title:
Clinical Evaluation of the Prismaflex HF20 Set and Prismaflex® System 7.10 for Acute CRRT in Children
| Verified date | June 2021 |
| Source | Baxter Healthcare Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 23 |
| Est. completion date | April 6, 2018 |
| Est. primary completion date | April 6, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Children's Medical Center of Dallas | Dallas | Texas |
| United States | Helen DeVos Children's Hospital | Grand Rapids | Michigan |
| United States | University of Iowa Children's Hospital | Iowa City | Iowa |
| United States | Seattle Children's Hospital - Divison of Nephrology | Seattle | Washington |
| United States | Lucile Packard Children's Hospital Stanford | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Baxter Healthcare Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life | 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 |
Up to 72 hours from CRRT initiation | |
| Primary | Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT | Blood Urea Nitrogen (BUN) | 24 hours from CRRT initiation | |
| Secondary | Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT | 24 hours from CRRT initiation | ||
| Secondary | Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT | 24 hours from CRRT initiation | ||
| Secondary | HF20 Set Filter Survival Time | 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. | Up to 72 Hours after Initiation |