Cystatin and Early AKI Detection Contrast Induced Acute K... | NCT07197957

Studies
Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury

NCT07197957

Sponsor

BayCare Health System

Status

Recruiting

Last Update Posted

Sep 30, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2025Actual

Primary Completion Date

Feb 28, 2026Estimated

Completion Date

Feb 28, 2027Estimated

First Submitted Date

Sep 25, 2025

First Submission Date that Met QC Criteria

Sep 25, 2025

First Posted Date

Sep 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2025

Last Update Posted Date

Sep 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		10 days

Secondary Outcomes

Measure	Description	Time Frame
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		10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tracy Johns, PharmD	Contact	727-519-1310		tracy.johns@baycare.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Morton Plant Hospital	Recruiting	Clearwater	Florida	33756	United States

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided