Back to resultsThe Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
Primary Purpose
Acute Kidney Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Kidney Failure focused on measuring Renal Replacement Therapy, Diuretics, Biomarkers, Renal Insufficiency, Furosemide, Therapeutic Uses, Physiological Effects of Drugs, Biological Markers
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of California-San Francisco
- George Washington University
- University of Chicago
- Johns Hopkins Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lasix
Arm Description
Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics
Outcomes
Primary Outcome Measures
Progression to Stage 3 AKI
The number of patients who progressed to Stage 3 during the time of observation
Receipt of Renal Replacement Therapy (RRT)
The number of patients who received renal replacement therapy (Dialysis)
Death
Inpatient mortality
Secondary Outcome Measures
Length of Intensive Care Unit (ICU) Stay
duration if ICU stay for all patients
Length of Hospital Stay
duration of the total hospital Stay for all patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01275729
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
June 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Failure
Keywords
Renal Replacement Therapy, Diuretics, Biomarkers, Renal Insufficiency, Furosemide, Therapeutic Uses, Physiological Effects of Drugs, Biological Markers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lasix
Arm Type
Experimental
Arm Description
Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Laisx
Intervention Description
dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Primary Outcome Measure Information:
Title
Progression to Stage 3 AKI
Description
The number of patients who progressed to Stage 3 during the time of observation
Time Frame
within 7 days of furosemide administration
Title
Receipt of Renal Replacement Therapy (RRT)
Description
The number of patients who received renal replacement therapy (Dialysis)
Time Frame
within 7 days of furosemide administration
Title
Death
Description
Inpatient mortality
Time Frame
During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Secondary Outcome Measure Information:
Title
Length of Intensive Care Unit (ICU) Stay
Description
duration if ICU stay for all patients
Time Frame
During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first
Title
Length of Hospital Stay
Description
duration of the total hospital Stay for all patients
Time Frame
During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay L Koyner, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
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The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
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