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This study aims to evaluate the clinical efficacy of Danhong injection in patients with septic myocardial injury through a prospective randomized controlled trial. The study will enroll 140 patients meeting criteria for septic myocardial injury, divided into a Danhong injection group and a placebo group. Primary endpoints include changes in myocardial injury markers and improvement rates in cardiac function over 7 days, while secondary endpoints include 28-day mortality rates. This will determine whether Danhong injection possesses myocardial protective effects and provide evidence-based support for expanding its clinical indications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danhong Injection | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danhong injection | Drug | Danhong Injection for intravenous drip, dosage: 20 ml, diluted in 80 ml of 0.9% saline solution for intravenous drip, twice daily, for a continuous treatment period of 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | 24 hours before treatment, 3 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac troponin T | Before treatment, 3 days after treatment, 7 days after treatment | |
| 28-day mortality | 28 days after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Saline | Drug | Intravenous drip of 100 ml 0.9% saline solution, twice daily, for 7 consecutive days. |
|
| ID | Term |
|---|---|
| C540581 | danhong |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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