Evaluation of Novel Biomarkers from Acutely Ill Patients at Risk for Acute Kidney Injury - Sapphire AST-111

Astute Medical, Inc. VP, Clinical & Regulatory Strategy0 个研究点目标入组 889 人开始时间: 2012年5月18日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Males and females 21 years of age or older;
•Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24 hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 24 hours prior to enrollment; Expected to remain in the ICU for at least 48 hours after enrollment; Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment; At least one of the following acute conditions within 24 hours prior to enrollment:
•(Respiratory SOFA score of = 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of = 1 (MAP < 70 mm Hg and/or any vasopressor required).
•Patient (or authorized representative) able and willing to provide written informed consent for study participation.

•Special populations including women with known pregnancy, prisoners or institutionalized individuals;
•Previous renal transplantation;
•Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3)
•Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);Patient meets any of the following:Active bleeding with an anticipated need for > 4 units PRBC;Hemoglobin < 7 g/dL;Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes.

发起方

Astute Medical, Inc. VP, Clinical & Regulatory Strategy