Sepsis
Conditions
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.
Interventions
DRUGAnisodamine hydrobromide combined with heparin
The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.
Sponsors
Chen Ying
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | Every patients' survival time will be observed on day 28 after admission. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Lactate clearance rate | The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission. |
Countries
China
Contacts
Primary ContactDong Hongmeng
Outcome results
None listed