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

This study is currently recruiting participants.
Verified February 2013 by George Washington University
Sponsor:
Information provided by (Responsible Party):
Lakhmir Chawla, George Washington University
ClinicalTrials.gov Identifier:
NCT00673244
First received: April 15, 2008
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Acute Kidney Failure
 Drug: Furosemide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Protocol to Assess the Severity of Acute Kidney Injury

Resource links provided by NLM:

Drug Information available for: Furosemide
U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673244

Contacts
Contact: Lakhmir S Chawla, MD 202-715-4570 lchawla@mfa.gwu.edu

Locations
United States, District of Columbia
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Lakhmir S Chawla, MD     202-715-4570     lchawla@mfa.gwu.edu    
Principal Investigator: Lakhmir S Chawla, MD            
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Lakmir S Chawla, MD George Washigton University
  More Information

Publications:

Responsible Party: Lakhmir Chawla, Associate Professor of Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT00673244     History of Changes
Other Study ID Numbers: IRB# 010835
Study First Received: April 15, 2008
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
Renal Replacement Therapy
Dialysis

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013