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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Failure
• Intervention / Treatment: Drug: Furosemide

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California-San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lasix; Pt to get dose of furosemide 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 Names: Laisx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression to Stage 3 AKI	The number of patients who progressed to Stage 3 during the time of observation	within 7 days of furosemide administration
Receipt of Renal Replacement Therapy (RRT)	The number of patients who received renal replacement therapy (Dialysis)	within 7 days of furosemide administration
Death	Inpatient mortality	During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Intensive Care Unit (ICU) Stay	duration if ICU stay for all patients	During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first
Length of Hospital Stay	duration of the total hospital Stay for all patients	During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Jay L Koyner, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimated): January 12, 2011

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Biomarkers; Renal Insufficiency; Diuretics; Physiological Effects of Drugs; Renal Replacement Therapy; Therapeutic Uses; Biological Markers; Furosemide
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: 10-503-B