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The preventive and therapeutic effects of Tongfu Yiqi Decoction on sepsis-induced myocardial injury-caused new-onset atrial fibrillation (NOAF) and the improvement in related prognosis.

The Preventive and Therapeutic Effects of Tongfu Yiqi Decoction on Sepsis-Induced Myocardial Injury-Related Newly Onset Atrial Fibrillation (NOAF) and Its Impact on Related Prognosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001623
Enrollment
Unknown
Registered
2026-06-26
Start date
2025-12-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Myocardial Injury

Interventions

Experimental Group:In addition to the routine treatment recommended by the SSC guidelines, Tongfu Yiqi Decoction (Rheum palmatum 9g, Citrus aurantium 6g, Panax ginseng 9g, Astragalus membranaceus 20g,
Control Group:Conventional treatment

Sponsors

Jiangsu Province Integrated Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Sign written informed consent to participate in the trial; be male or female, aged 18 years or older and less than 90 years old on the day of signing informed consent; patients with atrial fibrillation who developed new-onset atrial fibrillation confirmed by electrocardiogram during hospitalization, with no prior history of atrial fibrillation; patients with sepsis-associated myocardial injury receiving standard drug therapy for improved prognosis (diagnosed based on cardiac dysfunction or hemodynamic abnormalities in sepsis patients, combined with echocardiographic abnormalities and elevated myocardial injury biomarkers; sepsis: definite or suspected evidence of infection + SOFA score = 2 points; myocardial injury: elevated troponin levels exceeding the normal reference upper limit (99th percentile), cTnT > 0.01 ng/mL); patients may have outcomes such as new-onset atrial fibrillation, cardiogenic shock, days on endotracheal intubation, and mortality as prognostic indicators.

Exclusion criteria

Exclusion criteria: Had a clear history of atrial fibrillation before admission; hospitalization duration was too short (e.g., less than 24 hours); had chest trauma or received heart-related treatment (e.g., cardiopulmonary resuscitation, electrical cardioversion, or electrical defibrillation) within 7 days prior to this treatment; significant missing of key clinical data; pregnant or breastfeeding women; allergic constitution or patients allergic to traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
Incidence of NOAF;

Secondary

MeasureTime frame
Heart Function;Myocardial injury biomarkers;Inflammation and Intestinal Barrier Function;Disease severity;Disease-related protein;7-day mortality rate;28-day mortality rate;ICU hospital stay;Mechanical Ventilation Duration;

Countries

China

Contacts

Public ContactHuang Dan

Jiangsu Province Integrated Chinese and Western Medicine Hospital

huangdan@jsatcm.com13770822646

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026