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

NCT05634057 | Recruiting

• 1 other identifier: Z211100002921061
• Study Type: interventional
• Target: 782
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lactate clearance rate

  The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.

Study Arms (2)

Anisodamine hydrobromide combined with heparin

EXPERIMENTAL

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

conventional therapy

NO INTERVENTION

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.

Interventions

Anisodamine hydrobromide combined with heparin DRUG

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

Anisodamine hydrobromide combined with heparin

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years;
• Meets the diagnostic criteria for sepsis according to the "Sepsis-3" ;
• Patient or their legal representative consents to treatment and signs an informed consent form.

You may not qualify if:

• Patients expected to die within 24 hours after enrollment;
• Contraindications to low molecular weight heparin and scopolamine butylbromide drugs;
• Patients with thrombotic diseases requiring treatment with low molecular weight heparin;
• Patients with terminal-stage malignancies, severe immunodeficiency, immunosuppression, severe liver or kidney dysfunction (defined as liver or kidney SOFA score ≥ 3 points), etc.;
• Pregnant and lactating women;
• Patients participating in other clinical trials.

Sponsors & Collaborators

• Chen Ying: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China, 100020, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Dong Hongmeng

CONTACT

+8615210511650; donghongmeng@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research assistant；Junior technician

Model Details: The SEPSIS 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.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 1, 2022
• Study Start: January 25, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)