Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury

NCT ID: NCT07197957

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-11

Study Completion Date

2027-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BayCare Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Morton Plant Hospital

Clearwater, Florida, United States

Site Status RECRUITING

Morton Plant North Bay Hospital

New Port Richey, Florida, United States

Site Status RECRUITING

Mease Countryside Hospital

Safety Harbor, Florida, United States

Site Status RECRUITING

St. Anthony's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tracy Johns, PharmD

Role: CONTACT

727-519-1310

Facility Contacts

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Andrea Daigneault, RN

Role: primary

727-754-9028

Enrique Rincon, MD

Role: primary

727-375-7929

Jonathan Frunzi, MD

Role: primary

(727) 725-6111

Sarah Al-Obaydi, MD

Role: primary

727-825-1236

Other Identifiers

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Cystatin & Early AKI Detection

Identifier Type: -

Identifier Source: org_study_id

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