Contrast-associated Acute Kidney InjuryNCT07850947
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 of Contrast-associated Acute Kidney Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-associated Acute Kidney Injury
- What is being tested?
- Transdermal glomerular filtration rate (TGFR) monitoring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged ≥18 years old.
- Undergoing emergency contrast-enhanced CT examination.
- Patients who agree to participate in this observational study.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Shanxiang Xu, MD, +8613757119126, 2201027@zju.edu.cn
About this study
Official title: Study on the Association Between Baseline Transdermal Glomerular Filtration Rate and Contrast-Associated Acute Kidney Injury
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.
- Conditions
- Contrast-associated Acute Kidney Injury
- Being tested
- Transdermal glomerular filtration rate (TGFR) monitoring
- Keywords
- Contrast-associated acute kidney injury, Transdermal glomerular filtration rate, Emergency department, Contrast-enhanced CT, Acute kidney injury
- Medical subject headings
- Emergencies, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal glomerular filtration rate (TGFR) monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transdermal glomerular filtration rate (TGFR) monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours after contrast injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-associated Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850947
- Sponsor's protocol ID
- 2026-1075
- Other IDs
- 2026-1075
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association Between Baseline Transdermal Glomerular Filtration Rate and Contrast-Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07850947
- Acronym / sponsor ID
- 2026-1075
- Conditions
- Contrast-associated Acute Kidney Injury
- Keywords
- Contrast-associated acute kidney injury, Transdermal glomerular filtration rate, Emergency department, Contrast-enhanced CT, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency contrast-enhanced CT patients | – | Device: Transdermal glomerular filtration rate (TGFR) monitoringAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged ≥18 years old.
- Undergoing emergency contrast-enhanced CT examination.
- Patients who agree to participate in this observational study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal glomerular filtration rate (TGFR) monitoringNon-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. | Device | Emergency contrast-enhanced CT patients |
Primary outcome
Incidence of contrast-associated acute kidney injury (CA-AKI)
Time frame: Within 72 hours after contrast injection
Incidence of contrast-associated acute kidney injury within 72 hours after contrast media administration, defined by serum creatinine elevation criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast-associated Acute Kidney Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanxiang Xu, MD (+8613757119126, 2201027@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast-associated acute kidney injury (CA-AKI) (time frame: Within 72 hours after contrast injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.