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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasix | Experimental | Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Post renal AKI
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| Name | Affiliation | Role |
|---|---|---|
| Jay L Koyner, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-San Francisco | San Francisco | California | 94143 | United States | ||
| George Washington University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lasix | Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lasix | Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression to Stage 3 AKI | The number of patients who progressed to Stage 3 during the time of observation | Posted | Count of Participants | Participants | within 7 days of furosemide administration |
|
|
During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lasix | Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension- defined requiring intervention by means of fluid administration or vasopressor support | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay L Koyner | University of Chicago | 773-702-4842 | jkoyner@uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2015 | May 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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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 |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins Medicine | Baltimore | Maryland | 21205 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
| Primary | Receipt of Renal Replacement Therapy (RRT) | The number of patients who received renal replacement therapy (Dialysis) | Posted | Count of Participants | Participants | within 7 days of furosemide administration |
|
|
|
| Primary | Death | Inpatient mortality | Posted | Count of Participants | Participants | During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first |
|
|
|
| Secondary | Length of Intensive Care Unit (ICU) Stay | duration if ICU stay for all patients | Posted | Mean | Standard Error | days | During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first |
|
|
|
| Secondary | Length of Hospital Stay | duration of the total hospital Stay for all patients | Posted | Mean | Standard Error | days | During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first |
|
|
|
| 16 |
| 92 |
| 0 |
| 92 |
| 19 |
| 92 |
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |