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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Within 24 hours of sepsis diagnosis, patients received a daily intravenous infusion of 100 ml of Shenfu Injection for a continuous duration of 7 days.
empirical antimicrobial treatment (which is promptly administered after microbial tests), fluid (crystalloids) replacement (to be established according to fluid tolerance and fluid responsiveness), and vasoactive agents (e.g., norepinephrine (NE)), which are employed to maintain mean arterial pressure above 65 mmHg and reduce the risk of fluid overload
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGHR:heart rate
heart rate
Time frame: Day0,Day1,Day 3,Day 7
BP:Blood pressure
Blood pressure
Time frame: Day0,Day1,Day 3,Day 7
Proportion of perfused vessels
Grid-based score (3 horizontal and vertical equidistant lines). Percentage of perfused vessels per total number of vessel crossings
Time frame: Day0,Day1,Day 3,Day 7
Microvascular fow index
fow, 1 = intermittent fow, 2 = sluggish fow, 3 = normal fow Semi-quantitative assessment of the average red blood cell velocity per quadrant
Time frame: Day0,Day1,Day 3,Day 7
Heterogeneity index
Determinant of heterogeneity of blood fow, characteristic of distributive abnormalities
Time frame: Day0,Day1,Day 3,Day 7
Hemodynamic parameters1
CI: Cardio index
Time frame: Day0,Day1,Day 3,Day 7
Hemodynamic parameters2
SVRI:systemic vascular resistance index
Time frame: Day0,Day1,Day 3,Day 7
Hemodynamic parameters3
GEDVI:global end-diastolic volume index
Time frame: Day0,Day1,Day 3,Day 7
Ang2:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Time frame: Day0,Day1,Day 3,Day 7
VCAM1:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Time frame: Day0,Day1,Day 3,Day 7
Sydecan-1:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Time frame: Day0,Day1,Day 3,Day 7
6-Keto-PGF-1:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Time frame: Day0,Day1,Day 3,Day 7
TXB2:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Time frame: Day0,Day1,Day 3,Day 7
NO:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Time frame: Day0,Day1,Day 3,Day 7
Lab test1
PH
Time frame: Day0,Day1,Day 3,Day 7
Lab test2
PaO2 mmHg,
Time frame: Day0,Day1,Day 3,Day 7
Lab test3
PaCO2 mmHg
Time frame: Day0,Day1,Day 3,Day 7
Lab test4
Serum lactate mmol/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test5
IL-10 ng/ml
Time frame: Day0,Day1,Day 3,Day 7
Lab test6
WBC ×109/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test7
Neu ×109/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test8
Lym×109/L,
Time frame: Day0,Day1,Day 3,Day 7
Lab test9
Hb g/L,
Time frame: Day0,Day1,Day 3,Day 7
Lab test10
PLT×109/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test11
Total bilirubin IU/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test12
Cr μmol/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test13
IL-1βng/ml
Time frame: Day0,Day1,Day 3,Day 7
Lab test14
APTT s
Time frame: Day0,Day1,Day 3,Day 7
Lab test15
D-Dimermg/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test16
CRP mg/L
Time frame: Day0,Day1,Day 3,Day 7
Lab test17
ProBNP pg/ml
Time frame: Day0,Day1,Day 3,Day 7
Lab test18
PCT ng/ml
Time frame: Day0,Day1,Day 3,Day 7
Lab test19
TNFαng/ml
Time frame: Day0,Day1,Day 3,Day 7
Lab test20
IL-6 ng/ml
Time frame: Day0,Day1,Day 3,Day 7
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