Efficacy of Anisodamine Hydrobromide Combined With Heparin in the Treatment of Patients With Critical Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Heparin in the Treatment of Patients With Critical Infection

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Anisodamine hydrobromide combined with heparin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anisodamine hydrobromide combined with heparin<br>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<br>* The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.<br>|
| No Intervention: conventional therapy<br>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?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate clearance rate |  | The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission. |