Cystatin and Early AKI Detection Contra… | Clinical Trial

Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Morton Plant Hospital, Clearwater, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Tracy Johns, PharmD

CONTACT

[email protected]

727-519-1310

Sponsors and collaborators

Lead sponsor

BayCare Health System

Other

Registry information

Official study title

Clinical Utility of Cystatin C in the Early Detection of Contrast Induced Acute Kidney Injury

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Sep 30, 2025
Registry last updated: Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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