Protocol to Assess the Severity of Acute Kidney Injury

Study Overview
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Brief Summary
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The principal objective is to safely determine if we can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can predict the course of AKI (recovery v. RRT v. death)

Detailed Description
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AKI is a very common disease in the intensive care unit. However, despite advances in supportive care, patients with AKI carry a high mortality rate (50% to 70%). The established AKI affects nearly 5 percent of hospitalized persons and as many as 15 percent of critically ill patients. Currently, there are no FDA approved therapeutic agents for the treatment of AKI. Retrospective studies suggest that the early initiation of renal replacement therapy (RRT) improves outcome. Many clinicians tend to take a wait and see approach because they do not want to dialyze a patient who is destined to recover renal function without the need for RRT. Therefore, it is vitally important to know early in the course which patients with AKI are likely to progress to RRT.

Official Title
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Protocol to Assess the Severity 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 years and older Increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater or equal to 150 to 200% from baseline or sustained oliguria(mean urine output of <0.5 cc/kg/hr for 6 hours within 48 hours) Written informed consent Patients who already have a indwelling bladder catheter Exclusion Criteria: Voluntary refusal or missing written consent of the patient or the designated legal representative Patients with advanced Chronic Kidney Disease - as defined by a baseline GFR of < 30 ml/min as calculated by the MDRD equation Patients with renal transplantation Pregnancy Patients with an allergy or sensitivity to loop diuretics Patients with a clinical syndrome consistent with pre-renal AKI Defined by fractional excretion of Na of < 1% AND no evidence of the urinary casts, or Patients that are under-resuscitated as deemed by treating clinical team or Patients who are actively bleeding Patients with a clinical syndrome of post-renal AKI Any radiological study that shows hydro-ureter, or Clinical scenario wherein the obstruction is considered a likely possibility of the cause of AKI

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Furosemide<br>* One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.<br>* Other names: Lasix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Volume | Urine output measured in ml/hr for first 6 hours after furosemide administration | Time from furosemide administration to 6 hours after furosemide administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Replacement Therapy, Dialysis