Clinical Research on Shenfu Injection in Septic Patients

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Sepsis

Treatments: Drug: Shen-Fu; Drug: Norepinephrine (NE)，antibiotics，fluid resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06157320

320.6750.2022-2-35

Details and patient eligibility

About

Sepsis, characterized by organ dysfunction caused by infection, exhibits increasing incidence and mortality rates, posing a significant challenge to intensive care units. Early-stage sepsis involves hemodynamic disturbances, and severe and complex microcirculatory impairments can result in tissue hypoxia and accelerate organ dysfunction. Modern medical research has indicated that the effective and rapid restoration of microcirculatory function, along with the correction of microcirculatory disorders, is a crucial aspect in the treatment of sepsis. Current guidelines recommend the use of vasoactive drugs to address hemodynamic disturbances, but their administration may further damage the microcirculation. Additionally, in patients with severe sepsis, there often exists a disparity between macrocirculatory and microcirculatory hemodynamics, and conventional clinical indicators fail to directly reflect the level of microcirculatory perfusion.

Chinese guidelines have incorporated the use of traditional Chinese medicine (TCM) in the diagnosis and treatment of sepsis, offering a new therapeutic approach to ameliorate microcirculatory impairments. This study aims to include patients with sepsis and administer Shenfu Injection via intravenous therapy. Tongue microcirculation assessment will be employed to evaluate changes in microvascular health scores, while transcutaneous oxygen and carbon dioxide pressure alterations, as well as serum lactate level variations, will be monitored to ascertain the effects of Shenfu Injection on improving early-stage microcirculatory impairments and microvascular leakage in sepsis patients. This research will clarify the clinical efficacy of Shenfu Injection in sepsis patients with microcirculatory impairments, provide evidence-based medicine and clinical evidence for TCM treatment of sepsis, and offer a solid foundation for refining sepsis treatment strategies with distinct Chinese characteristics.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Shenfu Injection group

Experimental group

Description:

within 24 hours after the diagnosis of sepsis, Shenfu injection 100 ml/day, intravenous use, continuous application for 7 days.

Treatment:

Drug: Shen-Fu

Control group

Placebo Comparator group

Description:

sepsis was treated with standardized western medicine methods

Treatment:

Drug: Norepinephrine (NE)，antibiotics，fluid resuscitation