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

This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Jay Koyner, University of Chicago
ClinicalTrials.gov Identifier:
NCT01275729
First received: January 10, 2011
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


Condition Intervention
Acute Kidney Failure
 Drug: Furosemide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury

Resource links provided by NLM:

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

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Non-renal recovery [ Time Frame: 14 days or discharge ] [ Designated as safety issue: No ]
    need for RRT or persistant elevation of serum creatinine above pre-AKI baseline


Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lasix
Pt to get dose of furseomide 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

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 therapuetic 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 RRT. Additonally we will investigating the long term patient outcomes, 2-3 years after the index AKI admission.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 baselinie 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 kideny disease - as defined by a baseline GFR < 30 ml/min (MDRD)
  3. history of renal transplant
  4. Pregnant patients
  5. Allegery / Sensitivity to Loop diuretics (furosemide)

  6. Pre-renal AKI

    • defined by a FENa of < 1% and no urinary casts
    • under-resuscitatedas per the treating clinical team
    • active bleed

  7. Post renal AKI

    • evidence of hydro-ureter
    • clincal scenario wherein obstruction is considered a likely possibility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275729

Contacts
Contact: Jay L Koyner, MD 773-702-4842 jkoyner@uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jay L Koyner, MD     773-702-4842     jkoyner@uchicago.edu    
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jay L Koyner, MD University of Chicago
  More Information

No publications provided

Responsible Party: Jay Koyner, Assistant Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01275729     History of Changes
Other Study ID Numbers: Uchicago 10-503-B
Study First Received: January 10, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Renal Replacement Therapy
Diuretics
Biomarkers
Renal Insufficiency
 Furosemide
Therapeutic Uses
Physiological Effects of Drugs
Biological Markers

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

ClinicalTrials.gov processed this record on October 18, 2012