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

Sponsor

University of Chicago (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01275729

Collaborator

(none)

200

Enrollment

Locations

Arm

142

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Failure	Drug: Furosemide	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Non-renal recovery [14 days or discharge]
need for RRT or persistant elevation of serum creatinine above pre-AKI baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California-San Francisco	San Francisco	California	United States	94143
2	George Washington University	Washington	District of Columbia	United States	20037
3	University of Chicago	Chicago	Illinois	United States	60637
4	Johns Hopkins Medicine	Baltimore	Maryland	United States	21205