Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis

NCT ID: NCT05634057

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 782 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2025-12-31

Brief Summary

The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.

Detailed Description

Objective: The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.

Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically infected patients requiring vasopressor use. The critically infected patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.

Interim analysis will be performed. The primary study end point is 28-day mortality, and other secondary study endpoint is lactate clearance rate. The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental groups and the control group.

Discussion: The treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. The study will provide new insight into the treatment of patients with critical infection and can help to reduce mortality rate of critically infected patients.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Anisodamine hydrobromide combined with heparin

Anisodamine hydrobromide injection + low molecular weight heparin + basic treatment: The dosage of scopolamine butylbromide is 2.0mg/(kg\*d), administered via a micro-pump at a constant rate, continuously for 3 days. The dosage range for low molecular weight heparin is limited to 3000-6000U, administered subcutaneously once daily, continuously for 3 days.

Group Type: EXPERIMENTAL

Anisodamine hydrobromide combined with heparin

Intervention Type: DRUG

The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.

conventional therapy

Conventional treatment includes shock treatment, eliminating the cause of the condition, actively treating the primary disease, replenishing blood volume, correcting acid-base imbalances, using vasoactive drugs to maintain blood pressure, and advanced life support as needed, such as the use of a ventilator and bedside blood filtration for organ support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Anisodamine hydrobromide combined with heparin

The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Ying

OTHER

Sponsor Role: lead

Responsible Party

Chen Ying

Research assistant；Junior technician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dong Hongmeng

Role: CONTACT

donghongmeng@hotmail.com

+8615210511650

Facility Contacts

Dong Hongmeng

Role: primary

donghongmeng@hotmail.com

+8615210511650

Other Identifiers

Z211100002921061

Identifier Type: -

Identifier Source: org_study_id