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RecruitingNCT07197957Updated Sep 30, 2025

Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury

An observational study in Acute Kidney Injury, sponsored by BayCare Health System. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by BayCare Health System · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

To determine the clinical utility of serum cystatin C in early detection of acute kidney injury (AKI).

Read the detailed description

The primary objective of this study is to evaluate the clinical utility of Cystatin C in early detection of contrast-induced AKI.

To evaluate the effect of patient characteristics in the Cystatin C based GFR estimation in comparison to Cr based estimation.

02

Conditions studied

  • Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.

This study's planned enrollment of 100 is below the median of 151 across 772 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

BayCare Health System is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Study participants will be a cohort of inpatients with CKD. Eligible study participants, as defined by the inclusion criteria, will be consented at Morton Plant North Bay Hospital, Mease Countryside Hospital, and Morton Plant Hospital and St. Anthony's Hospital.

Inclusion criteria

  • Subjects ages 18 years and above
  • Inpatients with CKD (Figure 1)
  • Order for CT imaging study or coronary angiography with isohexol Omnipaque) contrast media.
  • Pre and post contrast available
  • All races and ethnicity of patients are eligible. We expect to analyze approximately equal number of men and women in this study.

Exclusion criteria

Exclusion Criteria:

  • Preexisting dialysis
  • Patients under the age of 18 years
  • Pregnancy
  • Incarcerated individuals
  • Patients with impaired cognition and unable to follow consent procedures
  • Recent exposure to CM (within 2 days before/after procedure)
  • Cardiac shock
  • Medications that affect biomarkers, including corticosteroids, lfamethoxazoletrimethoprim
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of AKI when sCr is used compared to when sCyC is used 24-48 hours after contract media and at 7-10 days follow-up

    Time frame: 10 days

Secondary outcomes

  1. Change from baseline in eGFRcr compared to change from baseline in eGFRcys 24-48 hours after contrast media and at 7 to 10 days follow-up

    Time frame: 10 days

07

Study locations

4 of 4 sites recruiting
  • Morton Plant Hospital
    Clearwater, Florida 33756, United States
    Recruiting
  • Morton Plant North Bay Hospital
    New Port Richey, Florida 34652, United States
    Recruiting
  • Mease Countryside Hospital
    Safety Harbor, Florida 34695, United States
    Recruiting
  • St. Anthony's Hospital
    St. Petersburg, Florida 33705, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07197957
Lead sponsor
BayCare Health System
Responsible party
Sponsor
First posted
Sep 30, 2025
Start date
Mar 11, 2025
Primary completion
Feb 28, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Sep 30, 2025

Study contacts

Tracy Johns, PharmD
Contact
tracy.johns@baycare.org
727-519-1310

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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