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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive. |
|
| 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 |
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Inclusion Criteria:
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
Patients with a clinical syndrome of post-renal AKI
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| Name | Affiliation | Role |
|---|---|---|
| Lakmir S Chawla, MD | George Washigton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6824004 | Background | Hou SH, Bushinsky DA, Wish JB, Cohen JJ, Harrington JT. Hospital-acquired renal insufficiency: a prospective study. Am J Med. 1983 Feb;74(2):243-8. doi: 10.1016/0002-9343(83)90618-6. | |
| 17699307 | Background | Liu KD, Himmelfarb J, Paganini E, Ikizler TA, Soroko SH, Mehta RL, Chertow GM. Timing of initiation of dialysis in critically ill patients with acute kidney injury. Clin J Am Soc Nephrol. 2006 Sep;1(5):915-9. doi: 10.2215/CJN.01430406. Epub 2006 Jul 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Did Not Progress to AKIN Stage III | Did not meet the following criteria within 14 days of furosemide stress test (FST): Need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours |
| FG001 | Progressed to AKIN Stage III | Meet the following criteria within 14 days of Furosemide stress test (FST): need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Progressed to AKIN Stage III |
| 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 | Urine Volume | Urine output measured in ml/hr for first 6 hours after furosemide administration | Posted | Mean | Standard Error | ml | Time from furosemide administration to 6 hours after furosemide administration |
|
14 days after furosemide stress test or until hospital discharge
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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 | Progressed to AKIN III | RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lakhmir S. Chawla | Department of Anesthesiology and Critical Care Medicine, George Washington University | 202-994-7903 | minkchawla@gmail.com |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 13733013 | Background | PARSONS FM, HOBSON SM, BLAGG CR, McCRACKEN BH. Optimum time for dialysis in acute reversible renal failure. Description and value of an improved dialyser with large surface area. Lancet. 1961 Jan 21;1(7169):129-34. doi: 10.1016/s0140-6736(61)91309-5. No abstract available. |
| 5926520 | Background | Fischer RP, Griffen WO Jr, Reiser M, Clark DS. Early dialysis in the treatment of acute renal failure. Surg Gynecol Obstet. 1966 Nov;123(5):1019-23. No abstract available. |
| 4545907 | Background | Kleinknecht D, Jungers P, Chanard J, Barbanel C, Ganeval D. Uremic and non-uremic complications in acute renal failure: Evaluation of early and frequent dialysis on prognosis. Kidney Int. 1972 Mar;1(3):190-6. doi: 10.1038/ki.1972.26. No abstract available. |
| 1202238 | Background | Conger JD. A controlled evaluation of prophylactic dialysis in post-traumatic acute renal failure. J Trauma. 1975 Dec;15(12):1056-63. doi: 10.1097/00005373-197512000-00003. No abstract available. |
| 10447537 | Background | Gettings LG, Reynolds HN, Scalea T. Outcome in post-traumatic acute renal failure when continuous renal replacement therapy is applied early vs. late. Intensive Care Med. 1999 Aug;25(8):805-13. doi: 10.1007/s001340050956. |
| 15108784 | Background | Demirkilic U, Kuralay E, Yenicesu M, Caglar K, Oz BS, Cingoz F, Gunay C, Yildirim V, Ceylan S, Arslan M, Vural A, Tatar H. Timing of replacement therapy for acute renal failure after cardiac surgery. J Card Surg. 2004 Jan-Feb;19(1):17-20. doi: 10.1111/j.0886-0440.2004.04004.x. |
| 15519198 | Background | Elahi MM, Lim MY, Joseph RN, Dhannapuneni RR, Spyt TJ. Early hemofiltration improves survival in post-cardiotomy patients with acute renal failure. Eur J Cardiothorac Surg. 2004 Nov;26(5):1027-31. doi: 10.1016/j.ejcts.2004.07.039. |
| 15312219 | Background | Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Congestive heart failure | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| NSAIDS | Count of Participants | Participants |
|
| Aminoglycosides | Count of Participants | Participants |
|
| Amphotericin | Count of Participants | Participants |
|
| Contrast | Count of Participants | Participants |
|
| Post-cardiac surgery | Count of Participants | Participants |
|
| Sepsis | Count of Participants | Participants |
|
| Baseline eGFR | Mean | Standard Deviation | ml/minute/1.73m2 |
|
| Baseline UFR | Mean | Standard Deviation | ml/hr |
|
| Furosemide-naïve | Count of Participants | Participants |
|
| Urinary Sediment Cast Scoring Index for Acute Kidney Injury | Urinary Sediment Cast Scoring Index is a biomarker for acute tubular necrosis which is the most common causes of acute kidney injury in hospitalized patients. Scores range from 1 to 4 with 1 being the best (no acute tubular necrosis) and 4 being the worst (severe acute tubular necrosis).
| Mean | Standard Deviation | Scores on a scale |
|
| FeNa above 1% | Count of Participants | Participants |
|
| Cardiovascular Sequential Organ Failure Assessment | This is sub-score of the sequential organ failure assessment score. Scores range from 0 (best) to 4 (worst). 0: MAP ≥ 70 mmHg, no vasopressors
| Mean | Standard Deviation | Scores on a scale |
|
| APACHE II score | APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. The score is an integer from 0 to 71 is computed based on 12 routine physiological measurements. Higher scores correspond to more severe disease and a higher risk of death. | Mean | Standard Deviation | Scores of a scale |
|
| AKIN stage at enrollment | The AKIN classification system uses creatinine and urine output to classify the severity of acute kidney injury. The stages range from 0 to 3. 0 means no acute kidney injury. 3 means most severe acute kidney injury.
| Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 9 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Did Not Progress to AKIN III | No RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test | 7 | 52 | 0 | 52 | 0 | 52 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |