Protocol to Assess the Severity of Acute Kidney Injury



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:3/1/2014
Start Date:April 2008
End Date:September 2013
Contact:Lakhmir S Chawla, MD
Email:lchawla@mfa.gwu.edu
Phone:202-715-4570

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The principal objective is to safely determine if we can identify the severity of Acute
Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood
and urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can
predict the course of AKI (recovery v. RRT v. death)

AKI is a very common disease in the intensive care unit. However, despite advances in
supportive care, patients with AKI carry a high mortality rate (50% to 70%). The established
AKI affects nearly 5 percent of hospitalized persons and as many as 15 percent of critically
ill patients. Currently, there are no FDA approved therapeutic agents for the treatment of
AKI.

Retrospective studies suggest that the early initiation of renal replacement therapy (RRT)
improves outcome. Many clinicians tend to take a "wait and see" approach because they do not
want to dialyze a patient who is destined to recover renal function without the need for
RRT. Therefore, it is vitally important to know early in the course which patients with AKI
are likely to progress to RRT.   

Inclusion Criteria:

- 18 years and older

- Increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater
or equal to 150 to 200% from baseline or sustained oliguria(mean urine output of <0.5
cc/kg/hr for 6 hours within 48 hours)

- Written informed consent

- Patients who already have a indwelling bladder catheter

Exclusion Criteria:

- Voluntary refusal or missing written consent of the patient or the designated legal
representative

- Patients with advanced Chronic Kidney Disease - as defined by a baseline GFR of < 30
ml/min as calculated by the MDRD equation

- Patients with renal transplantation

- Pregnancy

- Patients with an allergy or sensitivity to loop diuretics

- Patients with a clinical syndrome consistent with pre-renal AKI

- Defined by fractional excretion of Na of < 1% AND no evidence of the urinary
casts, or

- Patients that are under-resuscitated as deemed by treating clinical team or

- Patients who are actively bleeding

- Patients with a clinical syndrome of post-renal AKI

- Any radiological study that shows hydro-ureter, or

- Clinical scenario wherein the obstruction is considered a likely possibility of
the cause of AKI
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