Specimen Stability Study

Acute Kidney Injury Clinical Trial

Official title:

Urine Sample Processing Study:Analysis of Fresh Versus Frozen Urine Samples From Critically Ill Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846884
• Other study ID #: Opal
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: May 15, 2013
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Astute Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Males and females 21 years of age or older

2. 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

3. Expected to remain in the ICU for at least 48 hours after enrollment

4. Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment

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

Exclusion Criteria:

1. Special populations including children, pregnant women, and prisoners

2. Previous renal transplantation

3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment

4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)

5. Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)

6. Previously provided a urine sample and enrolled in this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astute Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.		6 months	No