Clinical Research on Shenfu Injection in Septic Patients
- Conditions
- Sepsis
- Interventions
- Registration Number
- NCT06157320
- Lead Sponsor
- Ruijin Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Age ≥ 18 years;
- Signed informed consent form;
- Meets sepsis 3.0 diagnostic 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Shenfu Injection group Shen-Fu within 24 hours after the diagnosis of sepsis, Shenfu injection 100 ml/day, intravenous use, continuous application for 7 days. Control group Norepinephrine (NE)，antibiotics，fluid resuscitation sepsis was treated with standardized western medicine methods
- Primary Outcome Measures
Name Time Method Heterogeneity index Day0，Day1，Day 3，Day 7 Determinant of heterogeneity of blood fow, characteristic of distributive abnormalities
HR:heart rate Day0，Day1，Day 3，Day 7 heart rate
Proportion of perfused vessels Day0，Day1，Day 3，Day 7 Grid-based score (3 horizontal and vertical equidistant lines). Percentage of perfused vessels per total number of vessel crossings
Hemodynamic parameters2 Day0，Day1，Day 3，Day 7 SVRI:systemic vascular resistance index
Hemodynamic parameters3 Day0，Day1，Day 3，Day 7 GEDVI:global end-diastolic volume index
Microvascular fow index Day0，Day1，Day 3，Day 7 fow, 1 = intermittent fow, 2 = sluggish fow, 3 = normal fow Semi-quantitative assessment of the average red blood cell velocity per quadrant
BP:Blood pressure Day0，Day1，Day 3，Day 7 Blood pressure
Hemodynamic parameters1 Day0，Day1，Day 3，Day 7 CI: Cardio index
- Secondary Outcome Measures
Name Time Method Ang2:Endothelial cell function indicators Day0，Day1，Day 3，Day 7 Endothelial cell function indicators got from the blood of patients
6-Keto-PGF-1:Endothelial cell function indicators Day0，Day1，Day 3，Day 7 Endothelial cell function indicators got from the blood of patients
Lab test5 Day0，Day1，Day 3，Day 7 IL-10 ng/ml
Lab test6 Day0，Day1，Day 3，Day 7 WBC ×109/L
Sydecan-1:Endothelial cell function indicators Day0，Day1，Day 3，Day 7 Endothelial cell function indicators got from the blood of patients
Lab test1 Day0，Day1，Day 3，Day 7 PH
Lab test2 Day0，Day1，Day 3，Day 7 PaO2 mmHg,
Lab test8 Day0，Day1，Day 3，Day 7 Lym×109/L,
Lab test13 Day0，Day1，Day 3，Day 7 IL-1βng/ml
Lab test14 Day0，Day1，Day 3，Day 7 APTT s
Lab test20 Day0，Day1，Day 3，Day 7 IL-6 ng/ml
Lab test10 Day0，Day1，Day 3，Day 7 PLT×109/L
Lab test4 Day0，Day1，Day 3，Day 7 Serum lactate mmol/L
Lab test16 Day0，Day1，Day 3，Day 7 CRP mg/L
VCAM1:Endothelial cell function indicators Day0，Day1，Day 3，Day 7 Endothelial cell function indicators got from the blood of patients
NO:Endothelial cell function indicators Day0，Day1，Day 3，Day 7 Endothelial cell function indicators got from the blood of patients
Lab test7 Day0，Day1，Day 3，Day 7 Neu ×109/L
Lab test9 Day0，Day1，Day 3，Day 7 Hb g/L,
Lab test12 Day0，Day1，Day 3，Day 7 Cr μmol/L
Lab test11 Day0，Day1，Day 3，Day 7 Total bilirubin IU/L
Lab test15 Day0，Day1，Day 3，Day 7 D-Dimermg/L
Lab test18 Day0，Day1，Day 3，Day 7 PCT ng/ml
Lab test19 Day0，Day1，Day 3，Day 7 TNFαng/ml
Lab test17 Day0，Day1，Day 3，Day 7 ProBNP pg/ml
TXB2:Endothelial cell function indicators Day0，Day1，Day 3，Day 7 Endothelial cell function indicators got from the blood of patients
Lab test3 Day0，Day1，Day 3，Day 7 PaCO2 mmHg
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China