Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection

September 23, 2023 updated by: Yi Han, Qianfoshan Hospital
To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
        • Contact:
      • Jinan, Shandong, China, 250014
        • Recruiting
        • China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients using sodium arsenite chloride injection from January 1, 2012 to December 31, 2022 approximately 400 people.

Description

Inclusion Criteria:

  • the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022
  • the patient used arsenite sodium chloride injection

Exclusion Criteria:

  • Patients with incomplete clinical information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arrhythmia
Time Frame: through study completion, an average of 1 year
Electrocardiogram shows arrhythmia with marked QT prolongation
through study completion, an average of 1 year
adverse reaction
Time Frame: through study completion, an average of 1 year
All cardiac-related adverse events in the course of the disease regimen
through study completion, an average of 1 year
troponin
Time Frame: through study completion, an average of 1 year
Troponin values
through study completion, an average of 1 year
Echocardiogram LVEF
Time Frame: through study completion, an average of 1 year
Echocardiogram LVEF values
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Investigators

  • Principal Investigator: Yi Han, doctorate, Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 23, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YSS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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