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Risk Prediction Model for Iodinated Contrast Medium Extravasation

Development and Validation of a Risk Prediction Model for Iodinated Contrast Medium Extravasation in Patients Undergoing Contrast-enhanced Computed Tomography

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06859242
Acronym
RPMICME
Enrollment
1000
Registered
2025-03-05
Start date
2025-01-25
Completion date
2026-11-30
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extravasation of Contrast Media

Keywords

Extravasation of Contrast Media, Predictive Models, Machine, Risk Management

Brief 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. 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).

Interventions

None listed

Sponsors

Zhang Wenyan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Volunteer to participate in this study. 2. Without contraindications such as iodine contrast allergy or hyperthyroidism. -

Exclusion criteria

1. There are communication barriers between researchers and patients. 2. Due to critical condition or unstable vital signs, patients should be transferred to relevant clinical departments for treatment or observation immediately after examination.

Design outcomes

Primary

MeasureTime frameDescription
accuracy of prediction modelthrough study completion, an average of 1 yearthe ratio of correct predictions to the total number of model predictions(%)
the incidence of peripheral venous iodine contrast agent extravasationOne 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(%)

Countries

China

Contacts

Primary ContactWenyan Zhang, Master
callmeanna1986@163.com0086-027-83663493
Backup ContactQin Li

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026