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Risk Prediction Model for Iodinated Contrast Medium Extravasation (RPMICME)

Z

Zhang Wenyan

Status

Enrolling

Conditions

Extravasation of Contrast Media

Study type

Observational

Funder types

Other

Identifiers

NCT06859242
2024D24 (Other Grant/Funding Number)
myanna2010

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Qin Li; Wenyan Zhang, Master

Data sourced from clinicaltrials.gov

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