Shenfu Injection Improves Arterial Vascular Reactivity

Phase 2

• Conditions: Shenfu; Vascular Reactivity; Septic Shock
• Interventions: Drug: shenfu injection

• Registration Number: NCT03749525
• Lead Sponsor: Jianfeng Xie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-09
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-20
• Study First Posted: 2018-11-21
• Last Update Posted: 2018-11-21
• Study Start: 2018-12-01
• Primary Completion: 2019-08
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	shenfu injection	shenfu injection
placebo group	shenfu injection	5% GS solution

Primary Outcome Measures

Name	Time	Method
The change of peripheral vascular resistance	day 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 Outcome Measures

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