Protocol to Assess the Severity of Acute Kidney Injury - Full Text View

Sponsor:	George Washington University
Information provided by:	George Washington University
ClinicalTrials.gov Identifier:	NCT00673244

Purpose

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)

Condition	Intervention
ACute Kidney Failure	Drug: Furosemide

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Protocol to Assess the Severity of Acute Kidney Injury

Resource links provided by NLM:

Drug Information available for: Furosemide

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:

Acute Kidney Injury requiring Renal Replacement Treatment Therapy [ Time Frame: 14 days or discharge (whichever occurs first) ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Furosemide One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive. Other Name: Lasix

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673244

Contacts

Contact: Lakhmir S Chawla, MD

202-715-4570

lchawla@mfa.gwu.edu

Locations

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

Sponsors and Collaborators

George Washington University

Investigators

Principal Investigator:

Lakmir S Chawla, MD

George Washigton University

More Information

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.

Responsible Party:	Lakhmir Chawla, GW Medical Faculty Associates
ClinicalTrials.gov Identifier:	NCT00673244 History of Changes
Other Study ID Numbers:	IRB# 010835
Study First Received:	April 15, 2008
Last Updated:	May 25, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by George Washington University:

Renal Replacement Therapy
Dialysis

Additional relevant MeSH terms:

Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012