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Shenfu Injection Improves Arterial Vascular Reactivity

Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03749525
Enrollment
26
Registered
2018-11-21
Start date
2018-12-01
Completion date
2019-09-30
Last updated
2018-11-21

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

Conditions

Septic Shock, Shenfu, Vascular Reactivity

Brief summary

Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and down-regulation of receptor sensitivity , and eventually cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are released during septic shock, in which inducible nitric oxide synthase (iNOS) and prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present, vasoactive drugs are widely used in clinically to improve vascular tone and are important means of circulation support. However, when the infection is heavier, the reactivity of the blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of the vasoactive drugs to maintain the circulation stability. At this time, the use of vasoactive drugs alone does not benefit patients with septic shock and may require the combination of other drugs.From the perspective of Chinese medicine, shock is a disease of yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This trial was designed to give patients with septic shock the use of Shenfu injection to determine the specific effects of Shenfu injection on vascular reactivity in patients with septic shock.

Interventions

we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock

Sponsors

Jianfeng Xie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. diagnosed as septic shock according to 2016 SSC Guidelines; 2. The dose of norepinephrine required to maintain MAP\>65mmHg ≥0.5μg/kg.min; 3. SVRI \<800 dyns/cm5.m2; 4. CI\>2.5L/min/m2; 5. The patient or the patient's family signed the informed consent form for this trial.

Exclusion criteria

1. septic shock occurs more than 24 hours; 2. Age \> 85 years old or \<18 years old; 3. pregnant or lactating women; 4. There are shock patients caused by other causes such as cardiogenicity and neurogenicity; 5. The terminal state of malignant tumor end-stage disease or the patient who is expected to die within 24 hours.

Design outcomes

Primary

MeasureTime frameDescription
The change of peripheral vascular resistanceday 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3

Secondary

MeasureTime frameDescription
Diastolic blood pressureday 1, day 2, day 3We will measure blood pressure every hour and diastolic blood pressure will be recorded per hour.
Dosage of vasoactive drugsday 1, day 2,day 3dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs 4/5000 dosages of adrenaline and norepinephrine

Contacts

Primary Contactsun qin, doc
sunqin1990@126.com86-15952083606

Outcome results

None listed

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