Acute Kidney Failure
Conditions
Keywords
Renal Replacement Therapy, Diuretics, Biomarkers, Renal Insufficiency, Furosemide, Therapeutic Uses, Physiological Effects of Drugs, Biological Markers
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.
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.
Interventions
DRUGFurosemide
dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 yrs or older 2. 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) 3. written informed consent 4. patients with an indwelling bladder catheter
Exclusion criteria
1. Voluntary refusal 2. Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) \< 30 ml/min (MDRD) 3. history of renal transplant 4. Pregnant patients 5. Allergy / Sensitivity to Loop diuretics (furosemide) 6. 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 7. Post renal AKI * evidence of hydro-ureter * clinical scenario wherein obstruction is considered a likely possibility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression to Stage 3 AKI | within 7 days of furosemide administration | The number of patients who progressed to Stage 3 during the time of observation |
| Receipt of Renal Replacement Therapy (RRT) | within 7 days of furosemide administration | The number of patients who received renal replacement therapy (Dialysis) |
| Death | During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first | Inpatient mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Intensive Care Unit (ICU) Stay | During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first | duration if ICU stay for all patients |
| Length of Hospital Stay | During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first | duration of the total hospital Stay for all patients |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lasix |
|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 14.68 |
| Race/Ethnicity, Customized African American | 42 participants |
| Race/Ethnicity, Customized Caucasian | 41 participants |
| Race/Ethnicity, Customized Native | 1 participants |
| Race/Ethnicity, Customized Other | 8 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 92 |
| other Total, other adverse events | 19 / 92 |
| serious Total, serious adverse events | 0 / 92 |
Outcome results
Primary
Death
Inpatient mortality
Time frame: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lasix | Death | 16 Participants |
Primary
Progression to Stage 3 AKI
The number of patients who progressed to Stage 3 during the time of observation
Time frame: within 7 days of furosemide administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lasix | Progression to Stage 3 AKI | 23 Participants |
Primary
Receipt of Renal Replacement Therapy (RRT)
The number of patients who received renal replacement therapy (Dialysis)
Time frame: within 7 days of furosemide administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lasix | Receipt of Renal Replacement Therapy (RRT) | 10 Participants |
Secondary
Length of Hospital Stay
duration of the total hospital Stay for all patients
Time frame: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lasix | Length of Hospital Stay | 17.29 days | Standard Error 2.4 |
Secondary
Length of Intensive Care Unit (ICU) Stay
duration if ICU stay for all patients
Time frame: During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lasix | Length of Intensive Care Unit (ICU) Stay | 9.15 days | Standard Error 1.45 |