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Clinical Trials/NCT06157320
NCT06157320
Recruiting
Not Applicable

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

Ruijin Hospital1 site in 1 country40 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Shen-Fu
Conditions
Sepsis
Sponsor
Ruijin Hospital
Enrollment
40
Locations
1
Primary Endpoint
Heterogeneity index
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
January 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Shenfu Injection group

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

Intervention: Shen-Fu

Control group

sepsis was treated with standardized western medicine methods

Intervention: Norepinephrine (NE),antibiotics,fluid resuscitation

Outcomes

Primary Outcomes

Heterogeneity index

Time Frame: Day0,Day1,Day 3,Day 7

Determinant of heterogeneity of blood fow, characteristic of distributive abnormalities

HR:heart rate

Time Frame: Day0,Day1,Day 3,Day 7

heart rate

Proportion of perfused vessels

Time Frame: 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

Time Frame: Day0,Day1,Day 3,Day 7

Blood pressure

Hemodynamic parameters1

Time Frame: Day0,Day1,Day 3,Day 7

CI: Cardio index

Hemodynamic parameters2

Time Frame: Day0,Day1,Day 3,Day 7

SVRI:systemic vascular resistance index

Hemodynamic parameters3

Time Frame: Day0,Day1,Day 3,Day 7

GEDVI:global end-diastolic volume index

Microvascular fow index

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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