VIDAS Nephroclear (NCL) CCL14 - Sample Stability

NCT05271617 | Completed

• 1 other identifier: B3166-CTPR01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This VIDAS® NEPHROCLEAR™ CCL14 (VIDAS® NCL™ CCL14) Sample Stability clinical trial is a multicenter, prospective, and qualitative study. The main study objective is to determine sample stability conditions for the VIDAS® NEPHROCLEAR™ CCL14 Test. This test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Sample stability conditions

  Detection of CCL14 levels in urine, spanning the measuring range of the assay for several sample conditions.

  one sample will be collected per participant, aliquots will be tested at various conditions: fresh, after one to two freeze-thaw cycles, after refrigeration for 24 hours and after 6 hours at room temperature

Interventions

VIDAS® NEPHROCLEAR™ CCL14 DIAGNOSTIC_TEST

Measurement of CCL14 in sample aliquots after being subjected to different testing conditions

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), who qualify based on the criteria described above. These participants are recruited under a separate protocol IRB approved protocol. This protocol covers testing of leftover samples only.

You may qualify if:

• Males and females 21 years of age or older;
• Receiving care in an intensive care unit;
• Expected to remain in the ICU for at least 48 hours after enrollment;
• Use of indwelling urinary catheter as standard care at the time of enrollment;
• Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
• Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
• Written informed consent provided by patient or legally authorized representative (LAR).

You may not qualify if:

• Prior kidney transplantation;
• Comfort-measures-only status;
• 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); (NOTE: HIV or hepatitis testing will not be performed for enrollment in this study.)
• Special populations, pregnant women, prisoners or institutionalized individuals;

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: March 10, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)