Recruiting

Cystatin C

Sponsor:

BayCare Health System

Code:

NCT07197957

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Acute Kidney Injury

Study ID

NCT07197957

Start date

Mar 11, 2025

Status verified date

Sep, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Tracy Johns, PharmD

727-519-1310tracy.johns@baycare.org

Locations

Morton Plant Hospital

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Andrea Daigneault, RN

727-754-9028andrea.daigneault@baycare.org

Morton Plant North Bay Hospital

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

Enrique Rincon, MD

727-375-7929enrique.rincon@baycare.org

Mease Countryside Hospital

Recruiting

Safety Harbor, Florida, United States, 34695

Contacts

Jonathan Frunzi, MD

(727) 725-6111johnathan.frunzi@baycare.org

St. Anthony's Hospital

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Sarah Al-Obaydi, MD

727-825-1236sarah.alobaydi@baycare.org

More Information

Sponsor

BayCare Health System

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BayCare Health System on 2025-09-30.