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

Acute Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275729
• Other study ID #: 10-503-B
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: June 2022

Study information

• Verified date: June 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	University of Chicago	Chicago	Illinois
United States	University of California-San Francisco	San Francisco	California
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Receipt of Renal Replacement Therapy (RRT)	The number of patients who received renal replacement therapy (Dialysis)	within 7 days of furosemide administration
Primary	Death	Inpatient mortality	During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Secondary	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
Secondary	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