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

NCT ID: NCT01275729

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2022-06-30

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.

Conditions

Acute Kidney Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lasix

Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: DRUG

dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Laisx

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay L Koyner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of California-San Francisco

San Francisco, California, United States

George Washington University

Washington D.C., District of Columbia, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

10-503-B

Identifier Type: -

Identifier Source: org_study_id