Shenfu Injection Improves Arterial Vascular Reactivity

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03749525
• Other study ID #: shenfu injection
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2018
• Est. completion date: September 2019

Study information

• Verified date: November 2018
• Source: Southeast University, China
• Contact: sun qin, doc
• Phone: 86-15952083606
• Email: sunqin1990[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shenfu
• Shock, Septic
• Vascular Reactivity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jianfeng Xie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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