Shenfu Injection Improves Arterial Vascular Reactivity

NCT ID: NCT03749525

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-09-30

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.

Conditions

Septic Shock; Shenfu; Vascular Reactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo group

5% GS solution

Group Type: PLACEBO_COMPARATOR

shenfu injection

Intervention Type: DRUG

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

control group

shenfu injection

Group Type: ACTIVE_COMPARATOR

shenfu injection

Intervention Type: DRUG

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

Interventions

shenfu injection

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

Intervention Type: DRUG

Other Intervention Names

5% GS solution

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianfeng Xie

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Xie

physician, sponsor-investigator,clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

haibo qin, professor

Role: STUDY_CHAIR

southeast university zhongda hospitial

Central Contacts

sun qin, doc

Role: CONTACT

sunqin1990@126.com

86-15952083606

Other Identifiers

shenfu injection

Identifier Type: -

Identifier Source: org_study_id