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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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
Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT
Blood Urea Nitrogen (BUN)
Time frame: 24 hours from CRRT initiation
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
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.
Time frame: Up to 72 Hours after Initiation
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Children's Medical Center of Dallas
Dallas, Texas, United States
Seattle Children's Hospital - Divison of Nephrology
Seattle, Washington, United States