Analyzing the risks of cardiotoxicity from sodium arsenite chloride injection
Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection
This study looks at whether using sodium arsenite chloride injections can harm the heart to help ensure the medication is safe for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 2 sites (Jinan, Shandong and 1 other locations) |
| Trial ID | NCT06060132 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the cardiotoxic effects associated with the use of sodium arsenite chloride injection by reviewing existing literature, monitoring data, and real-world applications. It will assess the risk rate of cardiotoxicity and conduct case analyses to determine the risk-benefit ratio of this medication. The findings will guide the marketing authorization holder in conducting further safety studies and implementing preventive measures to ensure safe drug use.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have received sodium arsenite chloride injection between January 1, 2012, and December 31, 2022.
Not a fit: Patients with incomplete clinical information will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety profile of sodium arsenite chloride injection, reducing the risk of cardiotoxicity in patients.
How similar studies have performed: While there may be existing studies on cardiotoxicity, this specific analysis of sodium arsenite chloride injection's risks appears to be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jinan, Shandong and 1 other locations
- China — Jinan, Shandong, China (Recruiting)
- First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ) — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Yi Han, doctorate — Qianfoshan Hospital
- Study coordinator: Yi Han, doctorate
- Email: 15552565120@163.com
- Phone: 15552565120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.