Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Details

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.

Keywords

Acute Kidney Failure, Renal Replacement Therapy, Diuretics, Biomarkers, Renal Insufficiency, Furosemide, Therapeutic Uses, Physiological Effects of Drugs, Biological Markers, Acute Kidney Injury, Lasix

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • University of California-San Francisco
    San Francisco California 94143 United States
  • University of Chicago
    Chicago Illinois 60637 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Chicago
ID
NCT01275729
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated