Acute Kidney Failure
Conditions
Keywords
Renal Replacement Therapy, Dialysis
Brief 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)
Detailed description
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.
Interventions
DRUGFurosemide
One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.
Sponsors
George Washington University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Volume | Time from furosemide administration to 6 hours after furosemide administration | Urine output measured in ml/hr for first 6 hours after furosemide administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Did Not Progress to AKIN Stage III Subject did not require RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST. | 52 |
| Progressed to AKIN Stage III Subject required RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST. | 25 |
| Total | 77 |
Baseline characteristics
| Characteristic | Did Not Progress to AKIN Stage III | Total | Progressed to AKIN Stage III |
|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 2.2 | 65.3 years STANDARD_DEVIATION 14 | 68.2 years STANDARD_DEVIATION 1.9 |
| AKIN stage at enrollment AKIN I | 34 Participants | 41 Participants | 7 Participants |
| AKIN stage at enrollment AKIN II | 18 Participants | 36 Participants | 18 Participants |
| Aminoglycosides | 0 Participants | 1 Participants | 1 Participants |
| Amphotericin | 2 Participants | 2 Participants | 0 Participants |
| APACHE II score | 16.5 Scores of a scale STANDARD_DEVIATION 1.2 | 17.8 Scores of a scale STANDARD_DEVIATION 1.11 | 21.6 Scores of a scale STANDARD_DEVIATION 2.5 |
| Baseline eGFR | 60.6 ml/minute/1.73m2 STANDARD_DEVIATION 8.8 | 68.6 ml/minute/1.73m2 STANDARD_DEVIATION 4.1 | 73.3 ml/minute/1.73m2 STANDARD_DEVIATION 4.2 |
| Baseline UFR | 95.7 ml/hr STANDARD_DEVIATION 16.3 | 74.6 ml/hr STANDARD_DEVIATION 11.6 | 29.7 ml/hr STANDARD_DEVIATION 4.2 |
| Cardiovascular Sequential Organ Failure Assessment | 1.05 Scores on a scale STANDARD_DEVIATION 0.2 | 1.16 Scores on a scale STANDARD_DEVIATION 0.3 | 1.5 Scores on a scale STANDARD_DEVIATION 0.4 |
| Chronic kidney disease | 17 Participants | 24 Participants | 7 Participants |
| Congestive heart failure | 15 Participants | 25 Participants | 10 Participants |
| Contrast | 15 Participants | 21 Participants | 6 Participants |
| Diabetes | 22 Participants | 35 Participants | 13 Participants |
| FeNa above 1% | 10 Participants | 14 Participants | 4 Participants |
| Furosemide-naïve | 23 Participants | 29 Participants | 6 Participants |
| Hypertension | 41 Participants | 60 Participants | 19 Participants |
| NSAIDS | 6 Participants | 8 Participants | 2 Participants |
| Post-cardiac surgery | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized African American | 29 Participants | 44 Participants | 15 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants | 23 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants | 10 Participants | 2 Participants |
| Sepsis | 12 Participants | 15 Participants | 3 Participants |
| Sex: Female, Male Female | 33 Participants | 44 Participants | 11 Participants |
| Sex: Female, Male Male | 19 Participants | 33 Participants | 14 Participants |
| Urinary Sediment Cast Scoring Index for Acute Kidney Injury | 2.1 Scores on a scale STANDARD_DEVIATION 0.16 | 2.3 Scores on a scale STANDARD_DEVIATION 0.13 | 2.7 Scores on a scale STANDARD_DEVIATION 0.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 25 | 7 / 52 |
| other Total, other adverse events | 0 / 25 | 0 / 52 |
| serious Total, serious adverse events | 0 / 25 | 0 / 52 |
Outcome results
Primary
Urine Volume
Urine output measured in ml/hr for first 6 hours after furosemide administration
Time frame: Time from furosemide administration to 6 hours after furosemide administration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressed to AKIN Stage III | Urine Volume | Urine Volume - Hour 1 | 89 ml | Standard Error 33 |
| Progressed to AKIN Stage III | Urine Volume | Urine Volume - Hour 2 | 96 ml | Standard Error 46.6 |
| Progressed to AKIN Stage III | Urine Volume | Urine Volume - Hour 3 | 109 ml | Standard Error 35.4 |
| Progressed to AKIN Stage III | Urine Volume | Urine Volume - Hour 4 | 88 ml | Standard Error 23.4 |
| Progressed to AKIN Stage III | Urine Volume | Urine Volume - Hour 5 | 83 ml | Standard Error 23.7 |
| Progressed to AKIN Stage III | Urine Volume | Urine Volume - Hour 6 | 75 ml | Standard Error 17.4 |
| Did Not Progress to AKIN Stage-III | Urine Volume | Urine Volume - Hour 5 | 219 ml | Standard Error 22.8 |
| Did Not Progress to AKIN Stage-III | Urine Volume | Urine Volume - Hour 1 | 329 ml | Standard Error 46 |
| Did Not Progress to AKIN Stage-III | Urine Volume | Urine Volume - Hour 4 | 265 ml | Standard Error 31.1 |
| Did Not Progress to AKIN Stage-III | Urine Volume | Urine Volume - Hour 2 | 392 ml | Standard Error 42.2 |
| Did Not Progress to AKIN Stage-III | Urine Volume | Urine Volume - Hour 6 | 194 ml | Standard Error 22.3 |
| Did Not Progress to AKIN Stage-III | Urine Volume | Urine Volume - Hour 3 | 311 ml | Standard Error 31.7 |