Evaluation of Novel Biomarkers from Acutely Ill Patients at Risk for Acute Kidney Injury

• Conditions: N17; Acute renal failure

• Registration Number: DRKS00003499
• Lead Sponsor: Astute Medical, Inc. VP, Clinical & Regulatory Strategy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-18
• Study Completion: 2012-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 889

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Of primary interest are biomarkers for the risk assessment for development of moderate or severe acute kidney injury (AKI) (RIFLE-I or RIFLE-F; AKIN 2 or AKIN 3), 24-48 hours prior to significant changes in serum creatinine or urine output.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes of interest include need for dialysis, mortality, ICU and hospital length of stay as well as longer-term outcomes such as recovery from AKI or development of CKD.