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Clinical Research on Shenfu Injection in Septic Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06157320
Enrollment
40
Registered
2023-12-05
Start date
2023-12-01
Completion date
2026-01-01
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, microcirculation, Shenfu Injection

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.

Interventions

DRUGShen-Fu

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.

DRUGNorepinephrine (NE),antibiotics,fluid resuscitation

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

Sponsors

Wu Jieping Medical Foundation
CollaboratorOTHER
Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HR:heart rateDay0,Day1,Day 3,Day 7heart rate
BP:Blood pressureDay0,Day1,Day 3,Day 7Blood pressure
Proportion of perfused vesselsDay0,Day1,Day 3,Day 7Grid-based score (3 horizontal and vertical equidistant lines). Percentage of perfused vessels per total number of vessel crossings
Microvascular fow indexDay0,Day1,Day 3,Day 7fow, 1 = intermittent fow, 2 = sluggish fow, 3 = normal fow Semi-quantitative assessment of the average red blood cell velocity per quadrant
Heterogeneity indexDay0,Day1,Day 3,Day 7Determinant of heterogeneity of blood fow, characteristic of distributive abnormalities
Hemodynamic parameters1Day0,Day1,Day 3,Day 7CI: Cardio index
Hemodynamic parameters2Day0,Day1,Day 3,Day 7SVRI:systemic vascular resistance index
Hemodynamic parameters3Day0,Day1,Day 3,Day 7GEDVI:global end-diastolic volume index

Secondary

MeasureTime frameDescription
Lab test17Day0,Day1,Day 3,Day 7ProBNP pg/ml
Lab test18Day0,Day1,Day 3,Day 7PCT ng/ml
Lab test19Day0,Day1,Day 3,Day 7TNFαng/ml
Lab test20Day0,Day1,Day 3,Day 7IL-6 ng/ml
TXB2:Endothelial cell function indicatorsDay0,Day1,Day 3,Day 7Endothelial cell function indicators got from the blood of patients
NO:Endothelial cell function indicatorsDay0,Day1,Day 3,Day 7Endothelial cell function indicators got from the blood of patients
Lab test1Day0,Day1,Day 3,Day 7PH
Lab test2Day0,Day1,Day 3,Day 7PaO2 mmHg,
Lab test3Day0,Day1,Day 3,Day 7PaCO2 mmHg
Lab test9Day0,Day1,Day 3,Day 7Hb g/L,
Lab test5Day0,Day1,Day 3,Day 7IL-10 ng/ml
Lab test6Day0,Day1,Day 3,Day 7WBC ×109/L
Lab test7Day0,Day1,Day 3,Day 7Neu ×109/L
Ang2:Endothelial cell function indicatorsDay0,Day1,Day 3,Day 7Endothelial cell function indicators got from the blood of patients
VCAM1:Endothelial cell function indicatorsDay0,Day1,Day 3,Day 7Endothelial cell function indicators got from the blood of patients
Sydecan-1:Endothelial cell function indicatorsDay0,Day1,Day 3,Day 7Endothelial cell function indicators got from the blood of patients
6-Keto-PGF-1:Endothelial cell function indicatorsDay0,Day1,Day 3,Day 7Endothelial cell function indicators got from the blood of patients
Lab test8Day0,Day1,Day 3,Day 7Lym×109/L,
Lab test4Day0,Day1,Day 3,Day 7Serum lactate mmol/L
Lab test10Day0,Day1,Day 3,Day 7PLT×109/L
Lab test11Day0,Day1,Day 3,Day 7Total bilirubin IU/L
Lab test12Day0,Day1,Day 3,Day 7Cr μmol/L
Lab test13Day0,Day1,Day 3,Day 7IL-1βng/ml
Lab test14Day0,Day1,Day 3,Day 7APTT s
Lab test15Day0,Day1,Day 3,Day 7D-Dimermg/L
Lab test16Day0,Day1,Day 3,Day 7CRP mg/L

Countries

China

Contacts

Primary ContactHongping Qu, phD,MD
hongpingqu0412@hotmail.com+86 13641801889
Backup ContactHongping Qu, phD,MD
hongpingqu0412@hotmail.com+86 13641801889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026