Protocol to Assess the Severity of Acute Kidney Injury

NCT00673244 | Completed Results

• 1 other identifier: IRB# 010835
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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)

Conditions

Acute Kidney Failure

Keywords

Renal Replacement Therapy; Dialysis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Furosemide

Interventions

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.

Also known as: Lasix

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (10)

• 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.

  PMID: 6824004 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.

  PMID: 17699307 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.

  PMID: 13733013 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.

  PMID: 5926520 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.

  PMID: 4545907 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.

  PMID: 1202238 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.

  PMID: 10447537 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.

  PMID: 15108784 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.

  PMID: 15519198 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.

  PMID: 15312219 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Lakhmir S. Chawla
• Organization: Department of Anesthesiology and Critical Care Medicine, George Washington University

minkchawla@gmail.com

202-994-7903

Study Officials

• Lakmir S Chawla, MD

  George Washigton University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: May 7, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 18, 2022
• Results First Posted: December 17, 2020

Record last verified: 2022-10

Locations

US (1)