MedPath

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

Not Applicable
Completed
Conditions
Acute Kidney Failure
Interventions
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
LasixFurosemidePt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics
Primary Outcome Measures
NameTimeMethod
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 AKIwithin 7 days of furosemide administration

The number of patients who progressed to Stage 3 during the time of observation

DeathDuring the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first

Inpatient mortality

Secondary Outcome Measures
NameTimeMethod
Length of Intensive Care Unit (ICU) StayDuring 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 StayDuring 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

© Copyright 2025. All Rights Reserved by MedPath