Risk Prediction Model for Iodinated Contrast Medium Extravasation

NCT ID: NCT06859242

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-25

Study Completion Date

2026-11-30

Brief Summary

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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

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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

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Extravasation of Contrast Media

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhang Wenyan

OTHER

Sponsor Role lead

Responsible Party

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Zhang Wenyan

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenyan Zhang, Master

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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TongjiHospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenyan Zhang, Master

Role: CONTACT

0086-027-83663493

Qin Li

Role: CONTACT

Facility Contacts

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Wenyan Zhang, Master

Role: primary

0086-027-83663493

Other Identifiers

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2024D24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

myanna2010

Identifier Type: -

Identifier Source: org_study_id

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