Protocol to Assess the Severity of Acute Kidney Injury

Condition(s) targeted: Acute Kidney Failure

Intervention: Furosemide (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: George Washington University

Official(s) and/or principal investigator(s):
Lakmir S Chawla, MD, Principal Investigator, Affiliation: George Washigton University

Overall contact:
Lakhmir S Chawla, MD, Phone: 202-715-4570, Email: lchawla@mfa.gwu.edu

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)

Official title: Protocol to Assess the Severity of Acute Kidney Injury

Study design: Prevention, Open Label, Single Group Assignment

Primary outcome: Acute Kidney Injury requiring Replacement Treatment Therapy

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.   

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Increase in serum creatinine of 0. 3 mg/dl over baseline within 72 hours of the initial

rise in creatinine; and/or decline in urine output - sustained oliguria (a 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:

- Under 18 years old

- 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%, 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

Lakhmir S Chawla, MD, Phone: 202-715-4570, Email: lchawla@mfa.gwu.edu

George Washington University Hospital, Washington, District of Columbia 20037, United States; Recruiting
Lakhmir S Chawla, MD, Phone: 202-715-4570, Email: lchawla@mfa.gwu.edu
Lakhmir S Chawla, MD, Principal Investigator

Related publications:

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.

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. Epub 2006 Jul 6.

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. No abstract available.

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.

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. No abstract available.

Conger JD. A controlled evaluation of prophylactic dialysis in post-traumatic acute renal failure. J Trauma. 1975 Dec;15(12):1056-63. No abstract available.

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.

Demirkiliç U, Kuralay E, Yenicesu M, Cağlar K, Oz BS, Cingöz F, Günay 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.

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.

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. Epub 2004 May 24. Review.

Starting date: April 2008
Ending date: April 2010
Last updated: May 5, 2008