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NCT Number: NCT06859242

Risk Prediction Model for Iodinated Contrast Medium Extravasation

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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(%)

  2. 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(%)

Study contacts

Contact information is provided by the study sponsor or research team.

Qin Li

CONTACT

Wenyan Zhang, Master

CONTACT

[email protected]

0086-027-83663493

Sponsors and collaborators

Lead sponsor

Zhang Wenyan

Other

Registry information

Official study title

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

Acronym: RPMICME

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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