Clinical trial NCT03749525: Shenfu Injection Improves Arterial Vascular Reactivity
Official title: Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Septic Shock
Shenfu
Vascular Reactivity
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of peripheral vascular resistance
timeFrame: day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: day 1, day 2, day 3
measure: Dosage of vasoactive drugs
timeFrame: day 1, day 2,day 3
Other outcomes:
Locations:
Study officials:
affiliation: southeast university zhongda hospitial
name: haibo qin, professor
role: STUDY_CHAIR
References: