AKI: Protocol to Assess the Severity of Acute Kidney Injury

• Sponsor: George Washington University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00673244
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arm: 1
• Duration (Months): 68
• Patients Per Site Per Month: 1.1

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Failure	Drug: Furosemide	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Protocol to Assess the Severity of Acute Kidney Injury
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Lasix

Outcome Measures

Primary Outcome Measures

1. Urine Volume [Time from furosemide administration to 6 hours after furosemide administration]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	George Washington University Hospital	Washington	District of Columbia	United States	20037

Sponsors and Collaborators

• George Washington University

Investigators

• Principal Investigator: Lakmir S Chawla, MD, George Washigton University

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Lakhmir Chawla, Associate Professor of Medicine, George Washington University
• ClinicalTrials.gov Identifier: NCT00673244
• Other Study ID Numbers: IRB# 010835
• First Posted: May 7, 2008
• Last Update Posted: Dec 17, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Lakhmir Chawla, Associate Professor of Medicine, George Washington University: Renal Replacement Therapy; Dialysis
• Additional relevant MeSH terms: Acute Kidney Injury; Renal Insufficiency; Furosemide

Study Results

Participant Flow

Arm/Group Title	Did Not Progress to AKIN Stage III	Progressed to AKIN Stage III
Arm/Group Description	Did not meet the following criteria within 14 days of furosemide stress test (FST): Need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours	Meet the following criteria within 14 days of Furosemide stress test (FST): need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours
Period Title: Overall Study
STARTED	52	25
COMPLETED	52	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Did Not Progress to AKIN Stage III	Progressed to AKIN Stage III	Total
Arm/Group Description	Subject did not require RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST.	Subject required RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST.	Total of all reporting groups
Overall Participants	52	25	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.8 (2.2)	68.2 (1.9)	65.3 (14.0)
Sex: Female, Male (Count of Participants)
Female	33 63.5%	11 44%	44 57.1%
Male	19 36.5%	14 56%	33 42.9%
Race/Ethnicity, Customized (Count of Participants)
African American	29 55.8%	15 60%	44 57.1%
Caucasian	15 28.8%	8 32%	23 29.9%
Hispanic	8 15.4%	2 8%	10 13%
Chronic kidney disease (Count of Participants)
Count of Participants [Participants]	17 32.7%	7 28%	24 31.2%
Hypertension (Count of Participants)
Count of Participants [Participants]	41 78.8%	19 76%	60 77.9%
Congestive heart failure (Count of Participants)
Count of Participants [Participants]	15 28.8%	10 40%	25 32.5%
Diabetes (Count of Participants)
Count of Participants [Participants]	22 42.3%	13 52%	35 45.5%
NSAIDS (Count of Participants)
Count of Participants [Participants]	6 11.5%	2 8%	8 10.4%
Aminoglycosides (Count of Participants)
Count of Participants [Participants]	0 0%	1 4%	1 1.3%
Amphotericin (Count of Participants)
Count of Participants [Participants]	2 3.8%	0 0%	2 2.6%
Contrast (Count of Participants)
Count of Participants [Participants]	15 28.8%	6 24%	21 27.3%
Post-cardiac surgery (Count of Participants)
Count of Participants [Participants]	6 11.5%	3 12%	9 11.7%
Sepsis (Count of Participants)
Count of Participants [Participants]	12 23.1%	3 12%	15 19.5%
Baseline eGFR (ml/minute/1.73m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/minute/1.73m2]	60.6 (8.8)	73.3 (4.2)	68.6 (4.1)
Baseline UFR (ml/hr) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/hr]	95.7 (16.3)	29.7 (4.2)	74.6 (11.6)
Furosemide-naïve (Count of Participants)
Count of Participants [Participants]	23 44.2%	6 24%	29 37.7%
Urinary Sediment Cast Scoring Index for Acute Kidney Injury (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	2.1 (0.16)	2.7 (0.23)	2.3 (0.13)
FeNa above 1% (Count of Participants)
Count of Participants [Participants]	10 19.2%	4 16%	14 18.2%
Cardiovascular Sequential Organ Failure Assessment (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	1.05 (0.2)	1.5 (0.4)	1.16 (0.3)
APACHE II score (Scores of a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores of a scale]	16.5 (1.2)	21.6 (2.5)	17.8 (1.11)
AKIN stage at enrollment (Count of Participants)
AKIN I	34 65.4%	7 28%	41 53.2%
AKIN II	18 34.6%	18 72%	36 46.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Progressed to AKIN Stage III	Did Not Progress to AKIN Stage-III
Arm/Group Description	Need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test.	Did not need RRT, have increase in serum creatinine of 300% over baseline, or have urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test.
Measure Participants	25	52
Urine Volume - Hour 1	89 (33)	329 (46)
Urine Volume - Hour 2	96 (46.6)	392 (42.2)
Urine Volume - Hour 3	109 (35.4)	311 (31.7)
Urine Volume - Hour 4	88 (23.4)	265 (31.1)
Urine Volume - Hour 5	83 (23.7)	219 (22.8)
Urine Volume - Hour 6	75 (17.4)	194 (22.3)

Adverse Events

Time Frame	14 days after furosemide stress test or until hospital discharge
Arm/Group Title	Progressed to AKIN III		Did Not Progress to AKIN III
Arm/Group Description	RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test		No RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test
All Cause Mortality
	Progressed to AKIN III		Did Not Progress to AKIN III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/25 (36%)		7/52 (13.5%)
Serious Adverse Events
	Progressed to AKIN III		Did Not Progress to AKIN III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Progressed to AKIN III		Did Not Progress to AKIN III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.