Clinical trial NCT06686355: The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula
Official title: Double-blind Randomized Parallel Contrast Clinical Study of Yiqilishui Formula on Sepsis Induced Myocardial Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sepsis Induced Myocardial Dysfunction
Keywords: sepsis
myocardial dysfunction
SIMD
Yiqilishui formula
Double-blind randomized
clinical study
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Inclusion criteria:

1. Patients hospitalized in the ICU of Beijing Tongzhou Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from January 2024 to December 2026.
2. Meeting the diagnostic criteria for Qi deficiency and water overflow syndrome of septic cardiomyopathy.
3. Age ≥50 and ≤80 years old;
4. SOFA score: 2 to 12 points;
5. Diagnosis of septic cardiomyopathy within 24 hours;
6. Patient or family member has signed the informed consent form.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Sepsis-induced myocardial dysfunction (SIMD) is characterized by high morbidity and mortality rates and remains a challenging issue in the field of critical care that has not yet been resolved. The main pathogenesis involves deficiency of Qi with water overflow and blood stasis and toxin blocking the channels. The use of a Qi-invigorating and diuretic formula has the effect of invigorating Qi, promoting diuresis, and detoxifying and unblocking the channels. This study employed a two-center prospective parallel randomized double-blind controlled trial, selecting a total of 80 SIMD subjects from the ICU of Tongzhou District Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Chinese Medicine, who met the inclusion and exclusion criteria. The subjects were randomly and evenly divided into a treatment group and a control group. Both groups received basic SIMD treatment, with the treatment group additionally receiving the oral or nasogastric administration of a granule preparation of Yiqilishui formula, and the control group receiving a placebo orally or nasogastrically. The intervention period was 7 days, with a follow-up period of 28 days. The primary efficacy indicators compared between the two groups were BNP and NT-proBNP, and the secondary efficacy indicators were echocardiography, myocardial injury markers, inflammatory markers, critical illness severity scores, ICU length of stay and costs, and 28-day survival rate. The study aimed to evaluate the clinical efficacy and safety of the Yiqilishui formula for SIMD.

Eligibility criteria: Inclusion Criteria

1. 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.
2. Patients diagnosed with SIMD and qi deficiency and water flooding syndrome.
3. Aged 50 to 80 years.
4. SOFA score: 2 to 12 points.
5. Diagnosis of SIMD within 24 hours.
6. Signed informed consent by the patient or their family.

Exclusion Criteria

1. Subjects diagnosed with acute coronary syndrome, old myocardial infarction, or those who have undergone coronary revascularization.
2. Subjects with heart failure caused by cardiomyopathies such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, or hypothyroid cardiomyopathy.
3. Subjects with heart failure caused by structural heart abnormalities, arrhythmias, pulmonary heart disease, or cardiorenal syndrome.
4. Subjects with severe primary diseases affecting survival, including uncontrolled, unresectable metastatic malignant tumors, hematologic diseases, and HIV.
5. Subjects with liver or kidney dysfunction, with an individual SOFA score of ≥3 for liver or kidney function.
6. Subjects who have used immunosuppressants continuously in the last 6 months or have undergone organ transplantation.
7. Subjects who have used corticosteroids (equivalent to methylprednisolone ≥20mg/day) continuously within 7 days prior to enrollment.
8. 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.
9. Subjects deemed unable to take decoctions by clinicians.
10. Pregnant or breastfeeding women.
11. Subjects with a body mass index (BMI) \<18.5 or \>30.
12. Subjects who have participated in other clinical trials within the last 30 days.
13. Subjects deemed unable to complete or unsuitable for this study by the researchers (e.g., expected death within 48 hours or refusal of active treatment).

Primary outcomes:
measure: BNP（B-type natriuretic peptide） decline rate
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Secondary outcomes:
measure: The levels of cTnI
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: The levels of CK-MB
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: Concentration of H-FABP
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: Tei index
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: MEE
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: LVMI
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: The levels of WBC
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: The percentage of NE%
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: The levels of CRP
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: The levels of PCT
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: Concentration of IL-6
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: Concentration of TNF-α
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: Concentration of ROS
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: Concentration of ATP
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: Platelet aggregation rate
timeFrame: At enrollment, on the 3rd day, the 7th day, and the 14th day
measure: SOFA score
timeFrame: At enrollment, the 7th day, and the 14th day
measure: Apache II score
timeFrame: At enrollment, the 7th day, and the 14th day
measure: ICU length of stay;
timeFrame: From the date the participant is transferred to the ICU to the date he or she is finally transferred out of the ICU, assessed up to 100 weeks.
measure: Outcome indicator
timeFrame: 28th day
Other outcomes:
measure: The level of body temperature
timeFrame: Daily from enrollment to the 7th day.
measure: Breathing rate
timeFrame: Daily from enrollment to the 7th day.
measure: Heart rate
timeFrame: Daily from enrollment to the 7th day.
measure: The levels of blood pressure
timeFrame: Daily from enrollment to the 7th day.
measure: The levels of ALT
timeFrame: At enrollment and on the 7th day.
measure: The levels of AST
timeFrame: At enrollment and on the 7th day.
measure: The levels of BUN
timeFrame: At enrollment and on the 7th day.
measure: The levels of Cr
timeFrame: At enrollment and on the 7th day.
measure: The levels of PT
timeFrame: At enrollment and on the 7th day.
measure: The levels of APTT
timeFrame: At enrollment and on the 7th day.
measure: The levels of INR
timeFrame: At enrollment and on the 7th day.
measure: The levels of TT
timeFrame: At enrollment and on the 7th day.
measure: The levels of D-D
timeFrame: At enrollment and on the 7th day.
measure: The levels of FDP
timeFrame: At enrollment and on the 7th day.
measure: Unexpected adverse reactions
timeFrame: From enrollment to the 7th day, unexpected adverse reactions should be recorded at any time during the intervention period.
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Study officials:
References: