ITMCTR2000003566
Recruiting
Phase 1
The clinical trial of the interventional effect of Sini Decoction and Shengxian Quyu Decoction on myocardial inhibition in patients with sepsis
Guangdong Provincial Hospital of Traditional Chinese Medicine0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnostic criteria of Western medicine:
- •1\. Patients with sepsis: (refer to the latest sepsis diagnostic criteria developed by SSC guidelines in 2016\)
- •(1\) Suspected or confirmed infection;
- •(2\) The sequential organ failure score (SOFA score) increased by 2 or more points above the baseline level, and it could be diagnosed as sepsis.
- •2\. Myocardial suppression: at present, there is no unified diagnostic standard for sepsis myocardial injury at home and abroad. At present, the domestic and foreign literatures are consulted and the diagnosis process recognized by well\-known experts is followed. The presence of any of the following is suggestive of myocardial suppression:
- •(1\) Myocardial injury markers: c\-tni \> 0\.03ng/ml and c\-tnt \> 0\.017ng/ml.
- •(2\) Echocardiography: LVEF \< 50%, or FS \> 25%.
- •Diagnostic criteria of traditional Chinese Medicine
- •(refer to the TCM classification of sepsis according to the guidelines for the treatment of severe sepsis / septic shock in China issued in 2014\)
- •1\. The body is tired and weak, with little Qi and lazy speech, pain in fixed parts, bleeding in some parts, and pain in chest and flank like needle pricking;
Exclusion Criteria
- •1\. Patients with severe hepatic and renal insufficiency, patients with severe immune diseases or malignant tumors;
- •2\. Patients with allergic constitution or allergic to traditional Chinese medicine decoction;
- •3\. Patients unable to cooperate with the study and patients who died within 24 hours after admission to ICU;
- •4\. Pregnant or lactating women;
- •5\. Patients who participated in other studies.
Outcomes
Primary Outcomes
Not specified
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