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Recruiting NCT07197957

Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury

Observational Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 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 outcome measures (1)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Morton Plant Hospital — Clearwater
  • Morton Plant North Bay Hospital — New Port Richey
  • Mease Countryside Hospital — Safety Harbor
  • St. Anthony's Hospital — St. Petersburg

Identifiers

NCT: NCT07197957 · Cystatin & Early AKI Detection

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗