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Not yet recruitingNCT07850947Updated Sep 30, 2026

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

An observational study in Contrast-associated Acute Kidney Injury, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This is a single-center, prospective observational study conducted in the emergency department. Adult patients who require contrast-enhanced computed tomography (CT) examination and have baseline estimated glomerular filtration rate (eGFR) ranging from 15 to 120 mL/min/1.73m² will be consecutively enrolled. Transdermal glomerular filtration rate (TGFR) monitoring will be implemented throughout the peri-contrast CT period. Baseline demographic information, clinical characteristics, laboratory parameters and contrast agent-related data will be collected. Serum creatinine will be tested after contrast exposure to identify cases of contrast-associated acute kidney injury (CA-AKI). The primary objective is to assess the predictive performance of TGFR for CA-AKI compared with conventional baseline eGFR. No study-related therapeutic interventions will be performed. All clinical managements follow routine emergency clinical practice. The total planned sample size is 30 subjects.

02

Conditions studied

  • Contrast-associated Acute Kidney Injury

Keywords

  • Contrast-associated acute kidney injury
  • Transdermal glomerular filtration rate
  • Emergency department
  • Contrast-enhanced CT
  • Acute kidney injury
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Inclusion criteria

  1. Aged ≥18 years old.
  2. Undergoing emergency contrast-enhanced CT examination.
  3. Patients who agree to participate in this observational study.

Exclusion criteria

Exclusion Criteria:

  1. History of end-stage renal disease receiving renal replacement therapy.
  2. Known allergy to iodinated contrast media.
  3. Pregnancy.
  4. Unable to complete 72-hour follow-up after contrast administration.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Emergency contrast-enhanced CT patients

    Adult emergency patients scheduled for contrast-enhanced CT. TGFR monitoring will be performed during peri-contrast period. No therapeutic intervention will be applied; all clinical management follows routine practice.

    Device: Transdermal glomerular filtration rate (TGFR) monitoring

Interventions

  • DeviceTransdermal glomerular filtration rate (TGFR) monitoring

    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.

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 site
  • The Second Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
07

References and documents

Study documents

  • Informed consent form · Sep 15, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data (IPD) of this study will not be shared with external researchers, to protect patient privacy and comply with Chinese healthcare data protection regulations.

08

Registry details

Key details

Study ID
NCT07850947
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Shanxiang Xu, MD
Contact
2201027@zju.edu.cn
+8613757119126

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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