REAL-ICU: Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU

• Sponsor: Biosite (Other)
• Overall Status: Completed
• CT.gov ID: NCT01294228
• Collaborator: (none)
• Enrollment: 1,001
• Locations: 28
• Duration (Months): 45
• Patients Per Site: 35.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a multi-center, prospective, observational study of patients that are admitted to the intensive care unit (ICU). This study does not include any treatment or intervention and it is considered Nonsignificant Risk.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury

Detailed Description

The study will be conducted in two phases. Phase One is specimen acquisition and subject diagnosis adjudication. Phase Two is biomarker testing.

Phase One

Approximately 850 adults admitted to general ICUs will be enrolled within 12 hours of receipt of ICU admission orders. Study specific whole blood and urine specimens will be collected.

There is an Adjudication Committee for this study. This committee is comprised of qualified, board-certified nephrologists.

Phase Two

During Phase Two, the plasma specimens will be divided amongst three clinical sites representative of the intended end users of this assay, and tested under a separate testing protocol.

Study Design

• Study Type: Observational
• Actual Enrollment: 1001 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Dec 1, 2014

Outcome Measures

Primary Outcome Measures

1. The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting. [Prior to or within 72 hours.]

   The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must be 21 years of age or older.

• Subjects must be admitted to an Intensive Care Unit (medical or surgical) and must be enrolled into this study within 12 hours of receipt of ICU admission orders.

• Subjects must be assessed as likely to be alive in the ICU for a minimum of 48 hours after enrollment.

• The following plasma/serum creatinine values must be available:

• Subjects that are admitted to the ICU following an elective surgery or procedure must have at least one pre-surgical/ pre-procedure creatinine value obtained in the 7 days prior to presentation to the ICU.

• Subjects that are admitted to the ICU for any reason other than following an elective surgery or procedure must have at least one creatinine value obtained greater than 7 days and up to 6 months prior to presentation to the ICU.

Exclusion Criteria

• Subjects either receiving or in imminent need of Renal Replacement Therapy.

• Subjects with evidence of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 (according to the 4-variable MDRD22).

• Subjects with any obstructive uropathy at the time of presentation to the ICU.

• Subjects with any known urothelial, urological or kidney malignancies.

• Subjects that have had any urologic procedure or surgery immediately prior to admission to the ICU.

• Subjects that have had any renal transplant or nephrectomy.

• Subjects that have had cardiovascular surgery involving cardiopulmonary bypass within the previous 7 days.

• Subjects that have participated in an interventional clinical study within the previous 30 days including studies with any investigational and non-investigational drugs.

• The inability to obtain written Informed Consent from the subject or an authorized representative.

• Subjects that have been previously enrolled in this study during a prior admission to the ICU.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LA County / USC Medical Center	Los Angeles	California	United States	90033
2	University of California, San Diego	San Diego	California	United States	92103
3	UC San Francisco General Hospital	San Francisco	California	United States	94110
4	St. Francis Sleep Allergy and Lungs	Clearwater	Florida	United States	33765
5	Queen's Medical Center	Honolulu	Hawaii	United States	96813
6	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
7	Kansas University Medical Center	Kansas City	Kansas	United States	66103
8	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
9	Henry Ford Health System	Detroit	Michigan	United States	48202
10	Cardiac and Vascular Research Center of Northern Michigan	Petoskey	Michigan	United States	49770
11	Mayo Clinic	Rochester	Minnesota	United States	55901
12	Washington University School of Medicine	St. Louis	Missouri	United States	63110
13	International Heart Institute of Montana	Missoula	Montana	United States	59802
14	Cooper University Hospital	Camden	New Jersey	United States	08103
15	New York Methodist Hospital	Brooklyn	New York	United States	11215
16	Mount Sinai Hospital	New York	New York	United States	10029
17	SUNY Stony Brook University Hospital	Stony Brook	New York	United States	11794
18	East Carolina University	Greenville	North Carolina	United States	27834
19	University Hospitals, Case Medical Center	Cleveland	Ohio	United States	44106
20	Cleveland Clinic	Cleveland	Ohio	United States	44195
21	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
22	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15261
23	Baylor College of Medicine	Houston	Texas	United States	77030
24	Providence Regional Medical Center	Everett	Washington	United States	98201
25	Swedish Medical Center	Seattle,	Washington	United States	98122
26	Vancouver Coastal Health	Vancouver	British Columbia	Canada	V5Z 1M9
27	St. Boniface Hospital	Winnepeg	Manitoba	Canada	R2H 2A6
28	Capitol District Health Authority	Halifax,	Nova Scotia	Canada	B3H 1V7

Sponsors and Collaborators

• Biosite

Investigators

• Principal Investigator: John Kellum, MD, University of Pittsburgh Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosite
• ClinicalTrials.gov Identifier: NCT01294228
• Other Study ID Numbers: BSTE-0409
• First Posted: Feb 11, 2011
• Last Update Posted: Feb 2, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	Clinical Study Population
Arm/Group Description	All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
Period Title: Overall Study
STARTED	1001
COMPLETED	1001
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Clinical Study Population
Arm/Group Description	All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
Overall Participants	871
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.7 (15.7)
Gender (Count of Participants)
Female	375 43.1%
Male	496 56.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	62 7.1%
Not Hispanic or Latino	809 92.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	16 1.8%
Asian	31 3.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	187 21.5%
White	625 71.8%
More than one race	0 0%
Unknown or Not Reported	12 1.4%
Region of Enrollment (participants) [Number]
Canada	81 9.3%
United States	790 90.7%

Outcome Measures

1. Primary Outcome

Title	The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.
Description	The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.
Time Frame	Prior to or within 72 hours.

Outcome Measure Data

Analysis Population Description

Study participants who had both an adjudicated AKI diagnosis and an evaluable T=0 (study enrollment) blood collection and associated test results.

Arm/Group Title	Clinical Study Population
Arm/Group Description	All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
Measure Participants	782
Number (95% Confidence Interval) [Probability]	0.671

Adverse Events

Time Frame	30 Days
Arm/Group Title	Clinical Study Population
Arm/Group Description	All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
All Cause Mortality
	Clinical Study Population
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Clinical Study Population
	Affected / at Risk (%)	# Events
Total	0/1001 (0%)
Other (Not Including Serious) Adverse Events
	Clinical Study Population
	Affected / at Risk (%)	# Events
Total	0/1001 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.