An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT

ConditionContrast-associated Acute Kidney Injury

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

This is a single-center, prospective observational study. We aim to evaluate the performance of transdermal glomerular filtration rate (TGFR) compared with baseline estimated glomerular filtration rate (eGFR) for early prediction of contrast-associated acute kidney injury (CA-AKI) in emergency patients scheduled for contrast-enhanced CT. Eligible participants are adult emergency patients with baseline eGFR between 15 and 120 mL/min/1.73m². TGFR monitoring will be performed during the peri-contrast CT period. We will collect clinical and laboratory data and follow up renal function after contrast exposure to analyze the predictive value of TGFR for CA-AKI. No extra therapeutic interventions will be applied in this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years old.

Undergoing emergency contrast-enhanced CT examination.

Patients who agree to participate in this observational study.

Disqualifiers

History of end-stage renal disease receiving renal replacement therapy.

Known allergy to iodinated contrast media.

Pregnancy.

Unable to complete 72-hour follow-up after contrast administration.

Trial population

Adult patients aged ≥18 years receiving emergency iodinated contrast-enhanced CT scan. We will observe the incidence of contrast-associated acute kidney injury and continuous transdermal renal monitoring.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Transdermal glomerular filtration rate (TGFR) monitoring
Device
Non-invasive transdermal glomerular filtration rate measurement performed during peri-contrast period for research observation only. No therapeutic treatment will be delivered. All clinical care remains routine standard care.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Emergency contrast-enhanced CT patients1 intervention

Trial outcomes

Primary outcomes

Incidence of contrast-associated acute kidney injury (CA-AKI)

Incidence of contrast-associated acute kidney injury within 72 hours after contrast media administration, defined by serum creatinine elevation criteria.

Time frame

Within 72 hours after contrast injection

Sponsors and contacts

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Second Affiliated Hospital, Zhejiang University, School of Medicine

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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