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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05634057
• Other study ID #: Z211100002921061
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 782
• Est. completion date: November 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• Anisodamine hydrobromide combined with heparin
The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chen Ying

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	The patients will be followed up for 28 days, as our usual hospital length of stay for critically infected patients is 28 days. The investigators will recorded the specific time of death.	Every patients' survival time will be observed on day 28 after admission.
Secondary	Lactate clearance rate		The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.