Shenfu Injection Improves Arterial Vascular Reactivity

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Reactivity, Septic Shock, Shenfu

Intervention / Treatment
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* Drug: shenfu injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed as septic shock according to 2016 SSC Guidelines; The dose of norepinephrine required to maintain MAP>65mmHg ≥0.5μg/kg.min; SVRI <800 dyns/cm5.m2; CI>2.5L/min/m2; The patient or the patient's family signed the informed consent form for this trial. Exclusion Criteria: septic shock occurs more than 24 hours; Age > 85 years old or <18 years old; pregnant or lactating women; There are shock patients caused by other causes such as cardiogenicity and neurogenicity; The terminal state of malignant tumor end-stage disease or the patient who is expected to die within 24 hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>5% GS solution | Drug: shenfu injection<br>* we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock<br>* Other names: 5% GS solution;|
| Active Comparator: control group<br>shenfu injection | Drug: shenfu injection<br>* we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock<br>* Other names: 5% GS solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of peripheral vascular resistance | Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3 | day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic blood pressure | We will measure blood pressure every hour and diastolic blood pressure will be recorded per hour. | day 1, day 2, day 3 | 
| Dosage of vasoactive drugs | dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs 4/5000 dosages of adrenaline and norepinephrine | day 1, day 2,day 3 |