The clinical trial of the interventional effect of Sini Decoction and Shengxian Quyu Decoction on myocardial inhibition in patients with sepsis

Phase 1

Recruiting

• Conditions: Sepsis

• Registration Number: ITMCTR2000003566
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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;
2. Light and dark tongue, purple purple or ecchymosis, varicose sublingual veins, and thin or stringy veins;
3. Cold sweat, cold limbs, red face, blue lips, or high fever, coma, etc.;
1. Meet the diagnostic criteria of sepsis myocardial suppression;
2. Syndrome differentiation of TCM is Qi deficiency and blood stasis;
3. Aged 18-85 years;
4. Excluding the patients with previous heart diseases;
5. Patients who voluntarily participated in the study and signed informed consent.

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Troponin-T;Echocardiography;pro-BNP;

Secondary Outcome Measures

Name	Time	Method
TNF-a;PCT;HMGB1;Qi deficiency and blood stasis scale score;SOFA;28-day mortality;CRP;IL-1ß;APACHE?;