Full Text View
Tabular View
No Study Results Posted
Related Studies
Protocol to Assess the Severity of Acute Kidney Injury (AKI)
This study is currently recruiting participants.
Study NCT00673244   Information provided by George Washington University
First Received: April 15, 2008   Last Updated: May 5, 2008   History of Changes

April 15, 2008
May 5, 2008
April 2008
February 2010   (final data collection date for primary outcome measure)
Acute Kidney Injury requiring Replacement Treatment Therapy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00673244 on ClinicalTrials.gov Archive Site
 
 
 
Protocol to Assess the Severity of Acute Kidney Injury
Protocol to Assess the Severity of Acute Kidney Injury

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.   

 
Interventional
Prevention, Open Label, Single Group Assignment
Acute Kidney Failure
Drug: Furosemide
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
150
April 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Increase in serum creatinine of 0.3 mg/dl over baseline within 72 hours of the initial rise in creatinine; and/or decline in urine output - sustained oliguria (a 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:

  • Under 18 years old
  • 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%, 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
Both
18 Years and older
No
Contact: Lakhmir S Chawla, MD 202-715-4570 lchawla@mfa.gwu.edu
United States
 
NCT00673244
Lakhmir Chawla, GW Medical Faculty Associates
IRB# 010835
George Washington University
 
Principal Investigator: Lakmir S Chawla, MD George Washigton University
George Washington University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP