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Protocol to Assess the Severity of Acute Kidney Injury (AKI)

Primary Purpose

Acute Kidney Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Furosemide

About this trial

This is an interventional prevention trial for Acute Kidney Failure focused on measuring Renal Replacement Therapy, Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

George Washington University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Urine Volume

Urine output measured in ml/hr for first 6 hours after furosemide administration

Secondary Outcome Measures

Full Information

NCT ID

NCT00673244

First Posted

April 15, 2008

Last Updated

October 12, 2022

Sponsor

George Washington University

1. Study Identification

Unique Protocol Identification Number

NCT00673244

Brief Title

Protocol to Assess the Severity of Acute Kidney Injury

Acronym

AKI

Official Title

Protocol to Assess the Severity of Acute Kidney Injury

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

George Washington University

4. Oversight

Data Monitoring Committee

5. Study Description

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Failure

Keywords

Renal Replacement Therapy, Dialysis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Furosemide

Other Intervention Name(s)

Lasix

Intervention Description

One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.

Primary Outcome Measure Information:

Title

Urine Volume

Description

Urine output measured in ml/hr for first 6 hours after furosemide administration

Time Frame

Time from furosemide administration to 6 hours after furosemide administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lakmir S Chawla, MD

Organizational Affiliation

George Washigton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

George Washington University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

6824004

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. doi: 10.1016/0002-9343(83)90618-6.

Results Reference

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PubMed Identifier

17699307

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. doi: 10.2215/CJN.01430406. Epub 2006 Jul 6.

Results Reference

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PubMed Identifier

13733013

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. doi: 10.1016/s0140-6736(61)91309-5. No abstract available.

Results Reference

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PubMed Identifier

5926520

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. No abstract available.

Results Reference

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PubMed Identifier

4545907

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. doi: 10.1038/ki.1972.26. No abstract available.

Results Reference

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PubMed Identifier

1202238

Citation

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.

Results Reference

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PubMed Identifier

10447537

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. doi: 10.1007/s001340050956.

Results Reference

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PubMed Identifier

15108784

Citation

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.

Results Reference

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PubMed Identifier

15519198

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. doi: 10.1016/j.ejcts.2004.07.039.

Results Reference

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PubMed Identifier

15312219

Citation

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.

Results Reference

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Protocol to Assess the Severity of Acute Kidney Injury

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