Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vantive Health LLC
With
Baxter Healthcare Corporation
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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).
