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NCT02121470 · ClinicalTrials.gov registry record
NGAL As An Aid for the Diagnosis of Acute Kidney Injury in Intensive Care
A clinical trial of Acute Kidney Injury, sponsored by BioPorto Diagnostics.
- Completed
- Registry status
- 252
- Enrollment target
- 4
- Study locations
NCT02121470: Completed study of Acute Kidney Injury, sponsored by BioPorto Diagnostics.
NCT02121470 is a study of Acute Kidney Injury that has completed, run by BioPorto Diagnostics. The registered enrollment target is 252 participants, below the 2,328-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02121470, a study of Acute Kidney Injury, has completed, sponsored by BioPorto Diagnostics.
- COMPLETED
- Registry status
- 252 participants
- Enrollment target
- 4
- Study locations
Study 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
Primary Outcome
Highest measured value used
Conditions Studied
Study Locations (4)
Massachusetts
- Massachusetts General Hospital - Boston
- Baystate Medical Center / WNERTA - Springfield
New York
- Montefiore Medical Center - The Bronx
Texas
- Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-06 |
What the finished NCT02121470 record still lists
NCT02121470 is an observational study that tracks outcomes without assigning an intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 2,328-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Acute Kidney Injury appearing as the primary indexed condition, and to 0 interventions.
NCT02121470 reports a single indexed study location in Massachusetts, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT02121470 about?
NCT02121470 is a clinical study titled "NGAL As An Aid for the Diagnosis of Acute Kidney Injury in Intensive Care". 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...
What is the current status of trial NCT02121470?
This trial is currently completed. The enrollment target is 252 participants. The study started on 2014-02. Estimated completion is 2015-06.
What conditions does trial NCT02121470 study?
This clinical trial studies the following conditions: Acute Kidney Injury.
Who is sponsoring clinical trial NCT02121470?
This trial is sponsored by BioPorto Diagnostics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02121470 being conducted?
This trial has 4 study locations across Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02121470's enrollment target sits among peer trials
252 29th of 74 higher than 46 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
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