Clinical trial NCT05634057: Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
Official title: Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 782
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 28-day mortality
timeFrame: Every patients' survival time will be observed on day 28 after admission.
Secondary outcomes:
measure: Lactate clearance rate
timeFrame: The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
Study officials:
References: