The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula (NCT06686355) | Clinical Trial Compass
RecruitingPhase 2
The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula
China80 participantsStarted 2024-11-20
Plain-language summary
The goal of this clinical trial is to learn if Chinese medicine - Yiqilishui formula works to treat sepsis-induced myocardial dysfunction (SIMD). It will also learn about the safety of Yiqilishui formula. The main questions it aims to answer are:
* Compared with conventional western traetment alone, can supplementing conventional Western treatment with Yiqilishui formula better improve the heart function and reduce mortality of participants with SIMD?
* What medical problems do participants have when taking Yiqilishui formula? Researchers will compare Yiqilishui formula to a placebo (a look-alike substance that contains no drug) to see if Yiqilishui formula works to treat SIMD.
Participants will:
* Take Yiqilishui formula granules or placebo twice daily for 7 days, while receiving standard conventional Western treatment.
* Undergo blood drawing, electrocardiogram and transthoracic echocardiography at enrollment, on the 3rd day, the 7th day, and the 14th day after enrollment.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patients hospitalized in the ICU of Tongzhou Traditional Chinese Medicine Hospital and Dongzhimen Hospital of Beijing University of Chinese Medicine between January 2024 and December 2026.
✓. Patients diagnosed with SIMD and qi deficiency and water flooding syndrome.
✓. Aged 50 to 85 years.
✓. SOFA score: 2 to 12 points.
✓. Diagnosis of SIMD within 24 hours.
✓. Signed informed consent by the patient or their family.
Exclusion criteria
✕. Subjects diagnosed with acute coronary syndrome.
✕. Subjects with heart failure caused by cardiomyopathies such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, or hypothyroid cardiomyopathy.
✕. Subjects with heart failure caused by structural heart abnormalities, arrhythmias, pulmonary heart disease, or cardiorenal syndrome.
What they're measuring
1
BNP（B-type natriuretic peptide） decline rate
Timeframe: At enrollment, on the 3rd day, the 7th day, and the 14th day
✕. Subjects with severe primary diseases affecting survival, including uncontrolled, unresectable metastatic malignant tumors, hematologic diseases, and HIV.
✕. Subjects with liver or kidney dysfunction, with an individual SOFA score of ≥3 for liver or kidney function.
✕. Subjects who have used immunosuppressants continuously in the last 6 months or have undergone organ transplantation.
✕. Subjects who have used corticosteroids (equivalent to methylprednisolone ≥20mg/day) continuously within 7 days prior to enrollment.
✕. Subjects who have used Chinese herbal medicines or Chinese patent medicine replenishing qi, activating blood circulation and facilitating diuresis within 14 days prior to enrollment.