Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

• Sponsor: Astute Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01209169
• Collaborator: (none)
• Enrollment: 890
• Locations: 35
• Duration (Months): 29
• Patients Per Site: 25.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury

Study Design

• Study Type: Observational
• Actual Enrollment: 890 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Outcome Measures

Primary Outcome Measures

1. Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI. [10/2010 to 2/2013]

   Primary outcome measure: Identification and Validation of Biomarkers from Acutely ill patients at risk for AKI. (N=744) Secondary outcomes including follow-up (N=890).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Males and females 21 years of age or older;

Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24 hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 24 hours prior to enrollment; Expected to remain in the ICU for at least 48 hours after enrollment; Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment; At least one of the following acute conditions within 24 hours prior to enrollment:

(Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required).

Patient (or authorized representative) able and willing to provide written informed consent for study participation.

Exclusion Criteria:

Special populations including women with known pregnancy, prisoners or institutionalized individuals;Previous renal transplantation;Known acutely worsening renal function prior to enrollment (e.g., any category of RIFLE criteria. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);Patient meets any of the following:Active bleeding with an anticipated need for > 4 units PRBC;Hemoglobin < 7 g/dL;Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa Intergrated Health System	Phoenix	Arizona	United States	85008
2	University of California San Diego	San Diego	California	United States	92103-8781
3	George Washington University	Washington	District of Columbia	United States	20037
4	University of Florida	Gainesville	Florida	United States	32610-0254
5	Bruce W. Carter Department of Veterans Affairs Medical Center	Miami	Florida	United States	33125
6	Tampa General Hospital	Tampa	Florida	United States	33606
7	Joseph M. Still Research Foundation, Inc.	Augusta	Georgia	United States	30909
8	University of Chicago Medical Center Section of Nephrology	Chicago	Illinois	United States	60637
9	University of Louisville	Louisville	Kentucky	United States	40202
10	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
11	Beth Israel Deaconess Med. Center (BIDMC)	Boston	Massachusetts	United States	02215
12	Providence Park Hospital	Novi	Michigan	United States	48374
13	Mayo Clinic	Rochester	Minnesota	United States	55905
14	Montefiore Medical Center	Bronx	New York	United States	10467
15	New York Methodist Hospital	Brooklyn	New York	United States	11215
16	Durham VA Medical Center	Durham	North Carolina	United States	27705
17	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
18	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15261
19	Virginia Commonwealth University	Richmond	Virginia	United States	23298
20	University Clinic for Internal Medicine	Innsbruck		Austria	6020
21	University of Alberta	Edmonton	Alberta	Canada	T6G 2B7
22	Edouard Herriot Hospital	Lyon		France	69003
23	Marc Jacquet Hospital	Melun		France	77000
24	Haut-Lévéque Hospital	Pessac		France	33600
25	UZ Brussel	Brussel	Belgium	Germany	1090
26	Ghent University Hospital	Ghent	Belgium	Germany	9000
27	Universitätsklinikum Aachen	Aachen		Germany	52074
28	Klinik für Anästhesie, Intensivmedizin und Schmerztherapie	Frankfurt		Germany	60590
29	Universitätsklinik Frankfurt am Main	Frankfurt		Germany	60590
30	Otto-von-Guericke-Universitat Magdeburg	Madgeburg		Germany	39120
31	Critical Care Center, Sabadell Hospital	Sabadell		Spain	08208
32	Karolinska University Hospital	Solna	Stockholm	Sweden	17176
33	Guy's and St. Thomas Hospital	London	England	United Kingdom	SE1 7EH
34	King's College Hospital	London	England	United Kingdom	SE5 9RS
35	Worthing Hospital	Worthing	West Sussex	United Kingdom	BN11 2DH

Sponsors and Collaborators

• Astute Medical, Inc.

Investigators

• Principal Investigator: John Kellum, MD, Professor, Critical Care Medicine, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Astute Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01209169
• Other Study ID Numbers: Sapphire
• First Posted: Sep 27, 2010
• Last Update Posted: Feb 22, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Astute Medical, Inc.: Kidney Renal
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Feb 22, 2013