Specimen Stability Study
Urine Sample Processing Study:Analysis of Fresh Versus Frozen Urine Samples From Critically Ill Subjects
1 other identifier
observational
124
1 country
6
Brief Summary
To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 6, 2013
CompletedMay 17, 2013
May 1, 2013
6 months
April 29, 2013
May 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.
6 months
Eligibility Criteria
Critically-ill adult subjects at risk for acute kidney injury.
You may qualify if:
- Males and females 21 years of age or older
- Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
- Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
- Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 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
- Subject (or authorized representative)able and willing to provide written informed consent for study participation
You may not qualify if:
- Special populations including children, pregnant women, and prisoners
- Previous renal transplantation
- 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)
- Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
- Previously provided a urine sample and enrolled in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Honolulu, Hawaii, 96813, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Port Jefferson, New York, 11777, United States
Unknown Facility
Greenville, North Carolina, 27834, United States
Related Publications (1)
Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.
PMID: 25237065DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 6, 2013
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 17, 2013
Record last verified: 2013-05