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Protocol to Assess the Severity of Acute Kidney Injury (AKI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00673244
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
Lakhmir Chawla, George Washington University

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)

Condition or disease Intervention/treatment Phase
Acute Kidney Failure Drug: Furosemide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Protocol to Assess the Severity of Acute Kidney Injury
Study Start Date : April 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: 1 Drug: Furosemide
One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.
Other Name: Lasix

Primary Outcome Measures :
  1. Patients meeting the definition for stage 3 of Acute Kidney injury as defined by the Acute Kidney Injury Network (AKIN-3) system. [ Time Frame: 14 days or discharge (whichever occurs first) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00673244

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United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
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Principal Investigator: Lakmir S Chawla, MD George Washigton University


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Responsible Party: Lakhmir Chawla, Associate Professor of Medicine, George Washington University Identifier: NCT00673244     History of Changes
Other Study ID Numbers: IRB# 010835
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Lakhmir Chawla, George Washington University:
Renal Replacement Therapy
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action