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The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury

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: NCT01275729
Recruitment Status : Active, not recruiting
First Posted : January 12, 2011
Last Update Posted : April 28, 2021
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the investigators will draw blood and urine for novel and standard biomarkers. The investigators are attempting to determine if these biomarkers can forecast the course of AKI (need for dialysis, death and renal recovery). The investigators seek to determine how well physicians caring for those with AKI can predict the clinical course compared to these novel biomarkers of AKI and if there is an association between clinical course and 3 year patient outcomes.

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

Detailed Description:
AKI is a very common disease in the setting of critical illness and carries an extremely high morbidity and mortality rate (over 50%). Currently there are no FDA approved therapeutic agents for the treatment of AKI. There is limited prospective evidence to guide nephrologists in terms of which patients will progress to more severe AKI in the setting of early AKI. Similarly, there is no evidence to guide nephrologists in terms of which patients will completely recover their renal function after AKI. Thus we need to know very early in the course of AKI which patients will progress and go on to require renal replacement therapy (RRT). Additionally we will investigating the long term patient outcomes, 2-3 years after the index AKI admission.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
Actual Study Start Date : December 2010
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Lasix
Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics
Drug: Furosemide
dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Other Name: Laisx

Primary Outcome Measures :
  1. Non-renal recovery [ Time Frame: 14 days or discharge ]
    need for RRT or persistant elevation of serum creatinine above pre-AKI baseline

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:

  1. 18 yrs or older
  2. increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (UOP < 0.5 cc/kg/hr for 6 hours with the last 48hours)
  3. written informed consent
  4. patients with an indwelling bladder catheter

Exclusion Criteria:

  1. Voluntary refusal
  2. Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) < 30 ml/min (MDRD)
  3. history of renal transplant
  4. Pregnant patients
  5. Allergy / Sensitivity to Loop diuretics (furosemide)
  6. Pre-renal AKI

    • defined by a Fractional Excretion of Sodium (FENa) of < 1% and no urinary casts
    • under-resuscitated as per the treating clinical team
    • active bleed
  7. Post renal AKI

    • evidence of hydro-ureter
    • clinical scenario wherein obstruction is considered a likely possibility

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): NCT01275729

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United States, California
University of California-San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Jay L Koyner, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT01275729    
Other Study ID Numbers: 10-503-B
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Keywords provided by University of Chicago:
Renal Replacement Therapy
Renal Insufficiency
Therapeutic Uses
Physiological Effects of Drugs
Biological Markers
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