The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study focuses on improving heart function in patients with life-threatening blood infections (septic shock). When the body fights severe infections, the heart sometimes struggles to pump blood effectively, which can lead to dangerous complications. Current treatments like intravenous fluids and blood pressure medications have limitations in protecting heart function. This multicenter clinical trial aims to evaluate whether adding Shenfu Injection - a traditional Chinese medicine preparation widely used to enhance cardiac function in cardiovascular diseases - to standard therapies can: 1. Prevent myocardial dysfunction during septic shock 2. Accelerate cardiac recovery if complications occur 3. Improve overall survival and clinical outcomes The randomized controlled design will compare therapeutic effects between two groups: one receiving standard septic shock treatment alone, and the other receiving standard treatment combined with Shenfu Injection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;

• 2\. Age ≥ 18 years.

Locations
Other Locations
China
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
RECRUITING
Wuhu
Contact Information
Primary
Qiancheng Xu
qianchengxu@wnmc.edu.cn
86-18297529106
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 440
Treatments
Experimental: Shenfu Injection Group
Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. On this basis, Shenfu Injection will be administered at a dosage of 50-100 ml (according to the medication practices of each participating center), diluted with an equal volume of 5% glucose and infused intravenously twice a day
No_intervention: Control Group
Treatment will be conducted in accordance with international and Chinese guidelines for sepsis.
Related Therapeutic Areas
Sponsors
Collaborators: The Fourth Affiliated Hospital of Anhui Medical University, Tongling People's Hospital, Guangde people's hospital, Wuhu County Traditional Chinese Medicine Hospital, Wuhu City Second People's Hospital, The Second Hospital of Anhui Medical University, Fuyang Traditional Chinese Medicine Hospital, The First People's Hospital of Bengb, Chaohu Hospital of Anhui Medical University, Suzhou Municipal Hospital of Anhui Province, the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China, Taihe County Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Anhui Medical University, Xuancheng people's hospital, The Third People's Hospital of Bengbu, Wuhu first people's hospital, Fuyang people's hospital
Leads: First Affiliated Hospital of Wannan Medical College

This content was sourced from clinicaltrials.gov