N/A
N=77
Protocol to Assess the Severity of Acute Kidney Injury
Acute Kidney Failure
Bottom Line
View on ClinicalTrials.gov: NCT00673244 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Urine Volume — 89; 329; 96; 392 ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Furosemide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- George Washington University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Volume |
89; 329; 96; 392; 109; 311 | — |
Summary
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)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00673244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.