NGAL As An Aid for the Diagnosis of Acute Kidney Injury in Intensive Care
The NGAL Test™ As An Aid for the Diagnosis of AKI in an Intensive Care Population, US
1 other identifier
observational
252
1 country
4
Brief Summary
Acute Kidney Injury (AKI) is a common and severe complication in critically ill patients which is associated with increased morbidity and mortality as well as high costs of medical care. NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a biomarker, that is expressed in several tissues including the kidneys. Renal expression of NGAL is dramatically increased in kidney injury from a variety of causes, and NGAL is released into both urine and plasma. NGAL levels rise within two hours of the insult, making NGAL an early and sensitive biomarker of kidney injury, with the potential to assist clinicians in managing patients at risk of kidney injury. This study is designed to validate the assigned NGAL cutoff value by comparing to clinical diagnosis of AKI as determined by current clinical practice in the US. The study sites will enroll consecutive ICU patients. Patients are given standard clinical care and lab-work. Each day, one additional urine and two additional plasma samples will be drawn and frozen. These additional samples are shipped to Sponsor for retrospective NGAL measurements. The duration of each subject´s participation will be until discharge from the ICU, or for a maximum 8 days, whichever comes first. In addition serum creatinine values will continue to be collected manually from the hospital data system for 48 hours after discharge from the ICU. (If subject has been in ICU for 8 or more days, the follow up values are collected while the patient is still in the ICU). 250 subjects will be enrolled in total at the three investigator sites. At least 40 patients must be enrolled at each site. The NGAL value will be matched to the "clinical diagnosis" of acute kidney injury (AKI) as specified by KDIGO® guidelines. The clinical diagnosis will be assigned by a three-person adjudication panel based on the entries in the eCRF by the investigators. Adjudicators are blinded for investigation site, AKI-diagnosis by treating physician, and NGAL values. A comparison of AKI diagnosis based on the cutoff value 250 ng/mL and clinical diagnosis as assigned by the majority of the adjudication panel will be conducted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedAugust 11, 2015
August 1, 2015
1.2 years
April 22, 2014
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NGAL (ng/mL)
Highest measured value used
Daily during ICU stay up to 8 days
Secondary Outcomes (2)
Creatinine
Daily during ICU stay up to 8 days + 2 days after discharge
Urine output
6h, 12h and 24h daily during ICU stay up to 8 days
Eligibility Criteria
Patients admitted to intensive care or critical care unit (all-comers)
You may qualify if:
- Admission to intensive care unit
- Informed consent
- Age ≥ 18 years.
You may not qualify if:
- History of nephrectomy, renal transplantation and/or renal replacement therapy initiated before admission
- Males and females aged 17 years or below
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Baystate Medical Center / WNERTA
Springfield, Massachusetts, 01199/01107, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Methodist Hospital
Houston, Texas, 77030, United States
Biospecimen
Urine, K3-EDTA Plasma, Li-Heparin Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter A McCullough, M.D.
St. John Providence Health System
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 23, 2014
Study Start
February 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
August 11, 2015
Record last verified: 2015-08