Shenfu Injection Improves Arterial Vascular Reactivity

NCT03749525 | Unknown Phase 2

• 1 other identifier: shenfu injection
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diastolic blood pressure

  day 1, day 2, day 3

• Dosage of vasoactive drugs

  day 1, day 2,day 3

Study Arms (2)

placebo group

PLACEBO COMPARATOR

5% GS solution

Drug: shenfu injection

control group

ACTIVE COMPARATOR

shenfu injection

Drug: shenfu injection

Interventions

shenfu injection DRUG

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

Also known as: 5% GS solution

control group; placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Han
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jianfeng Xie: lead

MeSH Terms

Conditions

Shock, Septic

Interventions

Shen-Fu

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• haibo qin, professor

  southeast university zhongda hospitial

  STUDY CHAIR

Central Study Contacts

sun qin, doc

CONTACT

86-15952083606; sunqin1990@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician, sponsor-investigator,clinical professor

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: November 21, 2018
• Study Start: December 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 21, 2018

Record last verified: 2018-11