Clinical trial NCT06157320: Clinical Research on Shenfu Injection in Septic Patients
Official title: Improving Microcirculation and Microvascular Leakage in Sepsis Patients: A Comprehensive Clinical Study of Shenfu Injection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: sepsis
microcirculation
Shenfu Injection
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Wu Jieping Medical Foundation
First posted: 2023-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: HR:heart rate
timeFrame: Day0，Day1，Day 3，Day 7
measure: BP:Blood pressure
timeFrame: Day0，Day1，Day 3，Day 7
measure: Proportion of perfused vessels
timeFrame: Day0，Day1，Day 3，Day 7
measure: Microvascular fow index
timeFrame: Day0，Day1，Day 3，Day 7
measure: Heterogeneity index
timeFrame: Day0，Day1，Day 3，Day 7
measure: Hemodynamic parameters1
timeFrame: Day0，Day1，Day 3，Day 7
measure: Hemodynamic parameters2
timeFrame: Day0，Day1，Day 3，Day 7
measure: Hemodynamic parameters3
timeFrame: Day0，Day1，Day 3，Day 7
Secondary outcomes:
measure: Ang2:Endothelial cell function indicators
timeFrame: Day0，Day1，Day 3，Day 7
measure: VCAM1:Endothelial cell function indicators
timeFrame: Day0，Day1，Day 3，Day 7
measure: Sydecan-1:Endothelial cell function indicators
timeFrame: Day0，Day1，Day 3，Day 7
measure: 6-Keto-PGF-1:Endothelial cell function indicators
timeFrame: Day0，Day1，Day 3，Day 7
measure: TXB2:Endothelial cell function indicators
timeFrame: Day0，Day1，Day 3，Day 7
measure: NO:Endothelial cell function indicators
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test1
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test2
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test3
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test4
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test5
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test6
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test7
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test8
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test9
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test10
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test11
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test12
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test13
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test14
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test15
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test16
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test17
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test18
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test19
timeFrame: Day0，Day1，Day 3，Day 7
measure: Lab test20
timeFrame: Day0，Day1，Day 3，Day 7
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital
name: Hongping Qu
role: STUDY_DIRECTOR
References:
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