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The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

Study acronym: SHIELD Trail
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 27, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06898723
Lead Sponsor First Affiliated Hospital of Wannan Medical College
Collaborators: Suzhou Municipal Hospital of Anhui Province, the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China, Wuhu County Traditional Chinese Medicine Hospital, Wuhu first people's hospital, Wuhu City Second People's Hospital, Xuancheng People's Hospital, Tongling People's Hospital, The Second Hospital of Anhui Medical University, The Fourth Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Anhui Medical University, The Third People's Hospital of Bengbu, Fuyang people's hospital, Chaohu Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, Guangde people's hospital, Fuyang Traditional Chinese Medicine Hospital, Taihe County Traditional Chinese Medicine Hospital
Conditions
(from sponsor)
Septic Cardiomyopathy, Septic Shock
Related terms Shock, Septic
Enrollment 440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov