Clinical Research on Shenfu Injection in Septic Patients
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
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.