Clinical trial NCT00673244: Protocol to Assess the Severity of Acute Kidney Injury
Official title: Protocol to Assess the Severity of Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Failure
Keywords: Renal Replacement Therapy
Dialysis
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Urine Volume
timeFrame: Time from furosemide administration to 6 hours after furosemide administration
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
Study officials:
affiliation: George Washigton University
name: Lakmir S Chawla, MD
role: PRINCIPAL_INVESTIGATOR
References:
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