Combining anisodamine hydrobromide and heparin to treat sepsis
Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
This study is testing if a new treatment combining anisodamine hydrobromide and heparin can help critically ill patients with sepsis live longer compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 782 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Locations | 1 site (Beijing, China) |
| Trial ID | NCT05634057 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of anisodamine hydrobromide combined with low-molecular-weight heparin in treating critically infected patients requiring vasopressor support. It is a multi-center randomized controlled trial where participants will be divided into groups receiving either conventional treatment or the new combination therapy. The primary endpoint is 28-day mortality, while secondary endpoints include lactate clearance rates. The goal is to determine if the new treatment can reduce mortality rates in patients with sepsis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with sepsis who require vasopressor treatment.
Not a fit: Patients expected to die within 24 hours of enrollment or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new alternative for improving survival rates in patients with sepsis.
How similar studies have performed: While this approach is novel, previous studies have explored various combinations of treatments for sepsis, but the specific combination of anisodamine hydrobromide and heparin has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Age greater than 18 years; 2. Meets the diagnostic criteria for sepsis according to the "Sepsis-3" ; 3. Patient or their legal representative consents to treatment and signs an informed consent form. Exclusion criteria: 1. Patients expected to die within 24 hours after enrollment; 2. Contraindications to low molecular weight heparin and scopolamine butylbromide drugs; 3. Patients with thrombotic diseases requiring treatment with low molecular weight heparin; 4. Patients with terminal-stage malignancies, severe immunodeficiency, immunosuppression, severe liver or kidney dysfunction (defined as liver or kidney SOFA score ≥ 3 points), etc.; 5. Pregnant and lactating women; 6. Patients participating in other clinical trials.
Where this trial is running
Beijing, China
- Beijing Chaoyang Hospital, Capital Medical University — Beijing, China, China (Recruiting)
Study contacts
- Study coordinator: Dong Hongmeng
- Email: donghongmeng@hotmail.com
- Phone: +8615210511650
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.