Clinical trial NCT01275729: The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
Official title: The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Failure
Keywords: Renal Replacement Therapy
Diuretics
Biomarkers
Renal Insufficiency
Furosemide
Therapeutic Uses
Physiological Effects of Drugs
Biological Markers
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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 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

Primary outcomes:
measure: Progression to Stage 3 AKI
timeFrame: within 7 days of furosemide administration
measure: Receipt of Renal Replacement Therapy (RRT)
timeFrame: within 7 days of furosemide administration
measure: Death
timeFrame: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Secondary outcomes:
measure: Length of Intensive Care Unit (ICU) Stay
timeFrame: During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first
measure: Length of Hospital Stay
timeFrame: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California-San Francisco
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: University of Chicago
name: Jay L Koyner, MD
role: PRINCIPAL_INVESTIGATOR
References: