Using Shenfu Injection to treat septic patients

Improving Microcirculation and Microvascular Leakage in Sepsis Patients: A Comprehensive Clinical Study of Shenfu Injection

This study is testing if Shenfu Injection can help improve blood flow and recovery in patients with sepsis when used with standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06157320 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Shenfu Injection on patients diagnosed with sepsis, a condition marked by severe infection and organ dysfunction. The study aims to restore microcirculatory function and address hemodynamic disturbances that are critical in the management of sepsis. Participants will receive Shenfu Injection alongside standard treatments such as norepinephrine, antibiotics, and fluid resuscitation. The trial seeks to evaluate the efficacy of this approach in improving patient outcomes and reducing the complications associated with sepsis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who meet the diagnostic criteria for sepsis.

Not a fit: Patients under 18, pregnant individuals, or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery rates and reduce mortality in septic patients.

How similar studies have performed: While the use of Shenfu Injection is less common in Western medicine, similar approaches targeting microcirculation in sepsis have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years;
* Signed informed consent form;
* Meets sepsis 3.0 diagnostic criteria;

Exclusion Criteria:

* Age \< 18 years;
* Known pregnancy;
* Inability to accept and complete signed informed consent within 24 hours of diagnosis of sepsis;
* Status of tracheal intubation;
* oral mucosal inflammation or damage;
* Patients with contraindications to transcutaneous oxygen partial pressure testing such as severe edema and burns;
* Concurrent participation in other treatment studies.

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hongping Qu, phD，MD

Conditions Sepsis; sepsis; microcirculation; Shenfu Injection