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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Kidney Failure

Intervention / Treatment
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* Drug: Furosemide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasix<br>Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics | Drug: Furosemide<br>* dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive<br>* Other names: Laisx;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Renal Insufficiency, Furosemide, Therapeutic Uses, Physiological Effects of Drugs, Biological Markers, Renal Replacement Therapy, Diuretics