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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Drug: Anisodamine hydrobromide combined with heparin

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.

• Study Type: Interventional
• Enrollment (Estimated): 782
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Hongmeng; Phone Number: +8615210511650; Email: donghongmeng@hotmail.com

Study Locations

• China
  • Beijing, China, 100020
    • Recruiting
    • Beijing Chaoyang Hospital, Capital Medical University
    • Contact: Dong Hongmeng; Phone Number: +8615210511650; Email: donghongmeng@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Anisodamine hydrobromide combined with heparin; The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Lactate clearance rate	The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.

Collaborators and Investigators

• Sponsor: Chen Ying

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Anti-Inflammatory Agents, Non-Steroidal; Fibrinolytic Agents; Antioxidants; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Free Radical Scavengers; Vasodilator Agents; Anticoagulants; Anti-Ulcer Agents; Parasympatholytics; Heparin; Anisodamine
• Other Study ID Numbers: Z211100002921061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No