Clinical trial NCT06859242: Risk Prediction Model for Iodinated Contrast Medium Extravasation
Official title: Development and Validation of a Risk Prediction Model for Iodinated Contrast Medium Extravasation in Patients Undergoing Contrast-enhanced Computed Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extravasation of Contrast Media
Keywords: Extravasation of Contrast Media
Predictive Models
Machine
Risk Management
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received enhanced CT scans via peripheral venous indwelling needle.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: accuracy of prediction model
timeFrame: through study completion, an average of 1 year
measure: the incidence of peripheral venous iodine contrast agent extravasation
timeFrame: One year before and after the prediction model is put into use.
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: TongjiHospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wenyan Zhang, Master
role: PRINCIPAL_INVESTIGATOR
References: