Extravasation of Contrast MediaRPMICMENCT06859242
Risk Prediction Model for Iodinated Contrast Medium Extravasation
An observational study of Extravasation of Contrast Media, run by Zhang Wenyan at 1 site in China.
Trial summary
This study aims to develop a risk prediction model for iodine contrast agent extravasation from peripheral veins and to implement this model clinically to establish a risk control management system for iodine contrast agent extravasation.A case-control study design was employed to collect data for model development. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extravasation of Contrast Media
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2025to 30 Nov 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who received enhanced CT scans via peripheral venous indwelling needle.
Who may be able to join
- Volunteer to participate in this study.
- Without contraindications such as iodine contrast allergy or hyperthyroidism. -
Who cannot join
- There are communication barriers between researchers and patients.
- Due to critical condition or unstable vital signs, patients should be transferred to relevant clinical departments for treatment or observation immediately after examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qin Li contact
China1 site, 1 recruiting
- Recruiting
TongjiHospital
Wuhan, Hubei, 430030
Wenyan Zhang, Master, 0086-027-83663493, callmeanna1986@163.com
About this study
Official title: Development and Validation of a Risk Prediction Model for Iodinated Contrast Medium Extravasation in Patients Undergoing Contrast-enhanced Computed Tomography
This study aims to develop a risk prediction model for iodine contrast agent extravasation from peripheral veins and to implement this model clinically to establish a risk control management system for iodine contrast agent extravasation.A case-control study design was employed to collect data for model development. The case group comprised patients who experienced iodine contrast agent extravasation during enhanced CT examinations, while the control group included patients who underwent similar examinations without extravasation.
Read the detailed description
In this study, a retrospective case-control design was utilized to collect data from patients who underwent enhanced CT examinations at our medical center. In line with the nursing management protocols of our center, all cases of iodine contrast extravasation require treatment and follow-up, necessitating the creation of an electronic record for each affected patient. During the establishment of these records, researchers obtained consent from the affected patients to include them in the study. Upon receiving approval, relevant data from the records were extracted for research purposes. For the non-extravasation group, researchers approached eligible patients or their guardians after the examination, explained the study's objectives, and collected pertinent data through Electronic Medical Record System after obtaining informed consent.
The collected data encompass general demographic information (including age, gender, height, and weight), medical history (including conditions such as malignant tumors, chemotherapy treatments, hypertension, and diabetes), and examination parameters (including specific examination items, types of contrast agents, injection dosages, and flow rates). Additionally, the dataset includes venous access details (such as vascular conditions, peripheral venous catheter insertion sites, and catheter models) and environmental factors (such as maximum and minimum temperatures and temperature variations).
- Conditions
- Extravasation of Contrast Media
- Keywords
- Extravasation of Contrast Media, Predictive Models, Machine, Risk Management
- Medical subject headings
- Extravasation of Diagnostic and Therapeutic Materials
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of prediction model
the ratio of correct predictions to the total number of model predictions(%)
Measured: through study completion, an average of 1 year
the incidence of peripheral venous iodine contrast agent extravasation
the number of iodine contrast agent extravasation times divided by the total number of enhanced CT examinations during the same period(%)
Measured: One year before and after the prediction model is put into use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start25 Jan 2025
- Primary completion31 May 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extravasation of Contrast MediaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Wenyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Wenyan, Tongji Hospital
- Investigators
- Wenyan Zhang, Master, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859242
- Sponsor's protocol ID
- myanna2010
- Other IDs
- 2024D24
- Acronym
- RPMICME
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Risk Prediction Model for Iodinated Contrast Medium Extravasation in Patients Undergoing Contrast-enhanced Computed Tomography
- ClinicalTrials.gov ID
- NCT06859242
- Acronym / sponsor ID
- RPMICME / myanna2010
- Conditions
- Extravasation of Contrast Media
- Keywords
- Extravasation of Contrast Media, Predictive Models, Machine, Risk Management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhang WenyanUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Mar 2025 (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 study aims to develop a risk prediction model for iodine contrast agent extravasation from peripheral veins and to implement this model clinically to establish a risk control management system for iodine contrast agent extravasation.A case-control study design was employed to collect data for model development. The case group comprised patients who experienced iodine contrast agent extravasation during enhanced CT examinations, while the control group included patients who underwent similar examinations without extravasation.
Detailed description
In this study, a retrospective case-control design was utilized to collect data from patients who underwent enhanced CT examinations at our medical center. In line with the nursing management protocols of our center, all cases of iodine contrast extravasation require treatment and follow-up, necessitating the creation of an electronic record for each affected patient. During the establishment of these records, researchers obtained consent from the affected patients to include them in the study. Upon receiving approval, relevant data from the records were extracted for research purposes. For the non-extravasation group, researchers approached eligible patients or their guardians after the examination, explained the study's objectives, and collected pertinent data through Electronic Medical Record System after obtaining informed consent.
The collected data encompass general demographic information (including age, gender, height, and weight), medical history (including conditions such as malignant tumors, chemotherapy treatments, hypertension, and diabetes), and examination parameters (including specific examination items, types of contrast agents, injection dosages, and flow rates). Additionally, the dataset includes venous access details (such as vascular conditions, peripheral venous catheter insertion sites, and catheter models) and environmental factors (such as maximum and minimum temperatures and temperature variations).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received enhanced CT scans via peripheral venous indwelling needle.
Key inclusion criteria (2 listed)
- Volunteer to participate in this study.
- Without contraindications such as iodine contrast allergy or hyperthyroidism. -
Key exclusion criteria (2 listed)
- There are communication barriers between researchers and patients.
- Due to critical condition or unstable vital signs, patients should be transferred to relevant clinical departments for treatment or observation immediately after examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy of prediction model
Time frame: through study completion, an average of 1 year
the ratio of correct predictions to the total number of model predictions(%)
the incidence of peripheral venous iodine contrast agent extravasation
Time frame: One year before and after the prediction model is put into use.
the number of iodine contrast agent extravasation times divided by the total number of enhanced CT examinations during the same period(%)
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 5 Mar 2025.
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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.
Qin Li contact
Wenyan Zhang, Master principal investigator
Tongji Hospital
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 Extravasation of Contrast Media, run by Zhang Wenyan 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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 Wenyan Zhang, Master (0086-027-83663493, callmeanna1986@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of prediction model (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 5 Mar 2025.