Cystatin C for early detection of contrast-induced acute kidney injury
Clinical Utility of Cystatin C in the Early Detection of Contrast Induced Acute Kidney Injury
We will test whether a blood test called cystatin C can detect contrast-induced acute kidney injury sooner than standard creatinine tests in adults with chronic kidney disease having contrast CT scans or coronary angiography.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BayCare Health System Academic / other |
| Locations | 4 sites (Clearwater, Florida and 3 other locations) |
| Trial ID | NCT07197957 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll adult inpatients with chronic kidney disease who are scheduled for contrast-enhanced CT imaging or coronary angiography at three BayCare hospitals in Florida. Blood samples will be collected before and after contrast exposure to measure serum cystatin C and creatinine and to calculate cystatin C–based and creatinine-based GFR estimates. The timing and magnitude of changes in cystatin C versus creatinine will be compared, and analyses will examine how patient characteristics influence cystatin C–based GFR estimation. Clinicians will manage care per usual practice while researchers collect and analyze laboratory and clinical data.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic kidney disease who are hospitalized and scheduled for contrast-enhanced CT or coronary angiography and who can provide informed consent are ideal candidates.
Not a fit: Patients already on dialysis, pregnant individuals, those recently exposed to contrast, incarcerated persons, or people taking medications known to alter the biomarkers are unlikely to benefit from the testing approach used here.
Why it matters
Potential benefit: If successful, earlier detection of AKI could allow faster treatment or preventive steps that may reduce kidney damage and the need for dialysis.
How similar studies have performed: Previous studies have shown that cystatin C can rise earlier than creatinine in acute kidney injury, but evidence specifically for contrast-induced AKI is supportive yet not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clearwater, Florida and 3 other locations
- Morton Plant Hospital — Clearwater, Florida, United States (Recruiting)
- Morton Plant North Bay Hospital — New Port Richey, Florida, United States (Recruiting)
- Mease Countryside Hospital — Safety Harbor, Florida, United States (Recruiting)
- St. Anthony's Hospital — St. Petersburg, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Tracy Johns, PharmD
- Email: tracy.johns@baycare.org
- Phone: 727-519-1310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.