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NCT Number: NCT06686355

The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula

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.

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Key information

Conditions

Sepsis Induced Myocardial Dysfunction Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, 100007, China

Location status: Recruiting

Location contact

Guoxia Zhang

CONTACT

[email protected]

86-84013192

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Subjects deemed unable to take decoctions by clinicians.
  • Pregnant or breastfeeding women.
  • Subjects who have participated in other clinical trials within the last 30 days.
  • 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).

Treatment and study plan

Yiqilishui formula

Drug

Astragalus Root 30g, Angelica sinensis 30g, Honeysuckle Flower 30g, Capillary Artemisia Herb 15g, Giant Knotweed Rhizome 15g, Lepidium Seed 30g, Sichuan Lovage Rhizome 15g, Salvia Root 15g, Jujube Fruit 15g;

Placebo

Other

5% Yiqilishui Granules + 95% Dextrin;

Primary outcomes

  1. BNP（B-type natriuretic peptide） decline rate

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Blood samples were taken from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day to measure the BNP levels in the subjects' venous blood, calculate the patient's BNP decline rate, assess the severity of heart failure in the subjects, and predict their prognosis.

Secondary outcomes

  1. The levels of cTnI

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of cardiac troponin I (cTnI)

  2. The levels of CK-MB

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of creatine kinase MB isoenzyme

  3. Concentration of H-FABP

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of heart-type fatty acid-binding protein

  4. Tei index

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, Tei index were measured using transthoracic echocardiography to evaluate the subjects' cardiac function and structure.

  5. MEE

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, myocardial energy expenditure

  6. LVMI

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, left ventricular mass index (LVMI) were measured using transthoracic echocardiography to evaluate the subjects' cardiac function and structure.

  7. The levels of WBC

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of white blood cells (WBC) in the subjects' venous blood is detected.

  8. The percentage of NE%

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The percentage of neutrophils (NE%) in the subjects' venous blood is detected.

  9. The levels of CRP

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of C-reactive protein (CRP) in the subjects' venous blood is detected.

  10. The levels of PCT

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of procalcitonin (PCT) in the subjects' venous blood is detected.

  11. Concentration of IL-6

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    The supernatant serum is obtained by centrifugation, and the levels of interleukin-6 (IL-6) is measured by ELISA.

  12. Concentration of TNF-α

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    The supernatant serum is obtained by centrifugation, and the levels of tumor necrosis factor-α (TNF-α) is measured by ELISA.

  13. Concentration of ROS

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    The supernatant serum is obtained by centrifugation, and reactive oxygen species (ROS)is measured by ELISA.

  14. Concentration of ATP

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    The supernatant serum is obtained by centrifugation, and the levels of ATP content in the subjects' serum is measured by ELISA.

  15. Platelet aggregation rate

    Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day

    At enrollment, D3, D7, and D14, venous blood from patients is collected, platelet-rich plasma is prepared using differential centrifugation, and the platelet aggregation rate is determined by optical turbidimetry.

  16. SOFA score

    Time frame: At enrollment, the 7th day, and the 14th day

    Sequential Organ Failure Assessment (SOFA score) is performed at the time of enrollment, on the 7th day, and on the 14th day. The SOFA score includes six systems: respiratory, circulation, liver, coagulation, kidney and central nervous system. Each system is scored according to different variables, with a score of 0 to 4 points, and a total score of 0 to 24 points. The higher the score, the worse the outcome.

  17. Apache II score

    Time frame: At enrollment, the 7th day, and the 14th day

    Acute Physiology and Chronic Health Evaluation (Apache II score) is performed at the time of enrollment, on the 7th day, and on the 14th day. The Apache II score is scored from 0 to 71, and the higher the score, the worse the outcome.

  18. ICU length of stay;

    Time frame: 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.

    ICU length of stay，up to 100 weeks.

  19. Outcome indicator

    Time frame: 28th day

    28-day mortality rate

Other outcomes

  1. The level of body temperature

    Time frame: Daily from enrollment to the 7th day.

    During the intervention period, record the patient's underarm temperature measurement daily.

  2. Breathing rate

    Time frame: Daily from enrollment to the 7th day.

    During the intervention period, record the patient's breathing rate measurement daily.

  3. Heart rate

    Time frame: Daily from enrollment to the 7th day.

    During the intervention period, record the patient's heart rate measurement daily.

  4. The levels of blood pressure

    Time frame: Daily from enrollment to the 7th day.

    During the intervention period, record the patient's blood pressure measurement daily.

  5. The levels of ALT

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of ALT.

  6. The levels of AST

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of AST.

  7. The levels of BUN

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of BUN.

  8. The levels of Cr

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of Cr.

  9. The levels of PT

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of Prothrombin Time(PT).

  10. The levels of APTT

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of Activated Partial Thromboplastin Time(APTT).

  11. The levels of INR

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of international normalized ratio(INR).

  12. The levels of TT

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of Thrombin Time(TT).

  13. The levels of D-D

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of D-dimer(D-D).

  14. The levels of FDP

    Time frame: At enrollment and on the 7th day.

    Before and after intervention period, record the patient's the levels of Fibrin degradation products(FDP).

  15. Unexpected adverse reactions

    Time frame: From enrollment to the 7th day, unexpected adverse reactions should be recorded at any time during the intervention period.

    Unexpected adverse reactions occurred during the intervention period.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoxia Zhang

CONTACT

[email protected]

+86-010-84013192

Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Official study title

Double-blind Randomized Parallel Contrast Clinical Study of Yiqilishui Formula on Sepsis Induced Myocardial Dysfunction

Acronym: YQSIMD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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