The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
- Registration Number
- NCT01275729
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 18 yrs or older
- 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)
- written informed consent
- patients with an indwelling bladder catheter
-
Voluntary refusal
-
Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) < 30 ml/min (MDRD)
-
history of renal transplant
-
Pregnant patients
-
Allergy / Sensitivity to Loop diuretics (furosemide)
-
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
-
Post renal AKI
- evidence of hydro-ureter
- clinical scenario wherein obstruction is considered a likely possibility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lasix Furosemide Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics
- Primary Outcome Measures
Name Time Method Receipt of Renal Replacement Therapy (RRT) within 7 days of furosemide administration The number of patients who received renal replacement therapy (Dialysis)
Progression to Stage 3 AKI within 7 days of furosemide administration The number of patients who progressed to Stage 3 during the time of observation
Death During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first Inpatient mortality
- Secondary Outcome Measures
Name Time Method Length of Intensive Care Unit (ICU) Stay During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first duration if ICU stay for all patients
Length of Hospital Stay During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first duration of the total hospital Stay for all patients
Trial Locations
- Locations (4)
Johns Hopkins Medicine
🇺🇸Baltimore, Maryland, United States
University of California-San Francisco
🇺🇸San Francisco, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
George Washington University
🇺🇸Washington, District of Columbia, United States