Effectiveness of Anisodamine Hydrobromide Combined With Heparin for the Treatment of Critically Ill Patients With Septic Shock
Study Details
Study Description
Brief Summary
The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of septic shock, in the hope that the therapy will provide alternatives to the treatment of septic shock.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Objective: The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of septic shock, in the hope that the therapy will provide alternatives to the treatment of septic shock.
Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically ill patients with septic shock requiring vasopressor use. The critically ill patients with septic shock will be randomly assigned to four groups in a ratio of 1:1:1:1. The groups will consist of the conventional treatment group, the anisodamine hydrobromide treatment group, the heparin 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 endpoints include lactate clearance rate at 6h, 24h, and 72h, ICU mortality, length of stay in ICU and hospital, organ failure free days.
The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental group 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 septic shock and can help to reduce mortality rate of septic shock.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: anisodamine hydrobromide The dosage of anisodamine hydrobromide is 1.2-4.0mg/ (kg·d) according to the condition, and the micropump will be used at constant speed. After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued. |
Drug: Anisodamine hydrobromide
The anisodamine hydrobromide treatment group is on the basis of conventional treatment.
Other Names:
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| Experimental: heparin The dosage of heparin is determined by the condition, 3000-6000U subcutaneous injection once a day; After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued. |
Drug: Heparin
The heparin treatment group is on the basis of conventional treatment.
|
| Experimental: Anisodamine hydrobromide combined with heparin The dosage of anisodamine hydrobromide is 1.2-4.0mg/(kg·d) according to the condition, and the micropump will be used at constant speed. The dosage of heparin, depending on the condition, is 3000-6000U subcutaneous injection once a day; After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued. |
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 antishock therapy, elimination of the cause, active treatment of the primary disease, replenishing blood volume, correcting acid-base imbalance, blood pressure maintenance with vasoactive drugs, and advanced life support, including advanced organ support such as ventilators and bedside hemofiltration, when the condition requires it. |
Outcome Measures
Primary Outcome Measures
- Hospital 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 septic shock patients is 28 days. The investigators will recorded the specific time of death.
Secondary Outcome Measures
- Lactate clearance rate [The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with septic shock
Exclusion Criteria:
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The age of <18 years or >80 years;
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Patients who were expected to die within 24h before enrollment;
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Patients who died or withdrew from the experiment due to serious diseases of heart, liver, kidney and other organs or mental diseases before reaching the end of the intervention effect;
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Patients had received treatment related to septic shock before enrollment, which may affect the observers of effect indicators;
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patients contraindicated with heparin and anisodamine;
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Refuse to sign the informed consent;
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Patients with thrombotic diseases requiring low molecular weight heparin treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chen Ying
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Z211100002921061