Protocol to Assess the Severity of Acute Kidney Injury

Acute Kidney Failure Clinical Trial

— AKI  

Official title:

Protocol to Assess the Severity of Acute Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673244
• Other study ID #: IRB# 010835
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: December 2013

Study information

• Verified date: October 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Conger JD. A controlled evaluation of prophylactic dialysis in post-traumatic acute renal failure. J Trauma. 1975 Dec;15(12):1056-63. — View Citation

Demirkiliç U, Kuralay E, Yenicesu M, Caglar 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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