跳至主要内容
临床试验/NCT06157320
NCT06157320招募中不适用

Improving Microcirculation and Microvascular Leakage in Sepsis Patients: A Comprehensive Clinical Study of Shenfu Injection

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Heterogeneity index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years;
  • Signed informed consent form;
  • Meets sepsis 3.0 diagnostic criteria;

排除标准

  • 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.

研究组 & 干预措施

Shenfu Injection group

Experimental

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

干预措施: Shen-Fu (Drug)

Control group

Placebo Comparator

sepsis was treated with standardized western medicine methods

干预措施: Norepinephrine (NE),antibiotics,fluid resuscitation (Drug)

结局指标

主要结局

Heterogeneity index

时间窗: Day0,Day1,Day 3,Day 7

Determinant of heterogeneity of blood fow, characteristic of distributive abnormalities

HR:heart rate

时间窗: Day0,Day1,Day 3,Day 7

heart rate

Proportion of perfused vessels

时间窗: 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

BP:Blood pressure

时间窗: Day0,Day1,Day 3,Day 7

Blood pressure

Hemodynamic parameters1

时间窗: Day0,Day1,Day 3,Day 7

CI: Cardio index

Hemodynamic parameters2

时间窗: Day0,Day1,Day 3,Day 7

SVRI:systemic vascular resistance index

Hemodynamic parameters3

时间窗: Day0,Day1,Day 3,Day 7

GEDVI:global end-diastolic volume index

Microvascular fow index

时间窗: 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

次要结局

  • 6-Keto-PGF-1:Endothelial cell function indicators(Day0,Day1,Day 3,Day 7)
  • Lab test5(Day0,Day1,Day 3,Day 7)
  • Ang2:Endothelial cell function indicators(Day0,Day1,Day 3,Day 7)
  • Lab test6(Day0,Day1,Day 3,Day 7)
  • Sydecan-1:Endothelial cell function indicators(Day0,Day1,Day 3,Day 7)
  • Lab test1(Day0,Day1,Day 3,Day 7)
  • Lab test2(Day0,Day1,Day 3,Day 7)
  • Lab test8(Day0,Day1,Day 3,Day 7)
  • TXB2:Endothelial cell function indicators(Day0,Day1,Day 3,Day 7)
  • Lab test3(Day0,Day1,Day 3,Day 7)
  • Lab test13(Day0,Day1,Day 3,Day 7)
  • Lab test14(Day0,Day1,Day 3,Day 7)
  • Lab test20(Day0,Day1,Day 3,Day 7)
  • Lab test10(Day0,Day1,Day 3,Day 7)
  • Lab test4(Day0,Day1,Day 3,Day 7)
  • Lab test16(Day0,Day1,Day 3,Day 7)
  • VCAM1:Endothelial cell function indicators(Day0,Day1,Day 3,Day 7)
  • NO:Endothelial cell function indicators(Day0,Day1,Day 3,Day 7)
  • Lab test7(Day0,Day1,Day 3,Day 7)
  • Lab test9(Day0,Day1,Day 3,Day 7)
  • Lab test12(Day0,Day1,Day 3,Day 7)
  • Lab test11(Day0,Day1,Day 3,Day 7)
  • Lab test15(Day0,Day1,Day 3,Day 7)
  • Lab test18(Day0,Day1,Day 3,Day 7)
  • Lab test19(Day0,Day1,Day 3,Day 7)
  • Lab test17(Day0,Day1,Day 3,Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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