NCT07850947

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
14mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Sep 2026Dec 2027

Study Start

First participant enrolled

September 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Contrast-associated acute kidney injuryTransdermal glomerular filtration rateEmergency departmentContrast-enhanced CTAcute kidney injury

Outcome Measures

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.

    Within 72 hours after contrast injection

Study Arms (1)

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

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.

Emergency contrast-enhanced CT patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

EmergenciesAcute Kidney Injury

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Shanxiang Xu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations