Shenfu Injection Improves Arterial Vascular Reactivity
Primary Purpose
Septic Shock, Shenfu, Vascular Reactivity
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
shenfu injection
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo group
control group
Arm Description
5% GS solution
shenfu injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Diastolic blood pressure
We will measure blood pressure every hour and diastolic blood pressure will be recorded per hour.
Dosage of vasoactive drugs
dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs
4/5000 dosages of adrenaline and norepinephrine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03749525
Brief Title
Shenfu Injection Improves Arterial Vascular Reactivity
Official Title
Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jianfeng Xie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Shenfu, Vascular Reactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
5% GS solution
Arm Title
control group
Arm Type
Active Comparator
Arm Description
shenfu injection
Intervention Type
Drug
Intervention Name(s)
shenfu injection
Other Intervention Name(s)
5% GS solution
Intervention Description
we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock
Primary Outcome Measure Information:
Title
The change of peripheral vascular resistance
Description
Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3
Time Frame
day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)
Secondary Outcome Measure Information:
Title
Diastolic blood pressure
Description
We will measure blood pressure every hour and diastolic blood pressure will be recorded per hour.
Time Frame
day 1, day 2, day 3
Title
Dosage of vasoactive drugs
Description
dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs
4/5000 dosages of adrenaline and norepinephrine
Time Frame
day 1, day 2,day 3
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Han
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sun qin, doc
Phone
86-15952083606
Email
sunqin1990@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
haibo qin, professor
Organizational Affiliation
southeast university zhongda hospitial
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Shenfu Injection Improves Arterial Vascular Reactivity
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