Shenfu Injection Improves Arterial Vascular Reactivity | NCT03749525

Studies
Shenfu Injection Improves Arterial Vascular Reactivity

NCT03749525

Sponsor

Jianfeng Xie

Status

Unknown status

Last Update Posted

Nov 21, 2018Actual

Enrollment

26Estimated

Phase

Phase 2Phase 3

Conditions

Septic Shock
Shenfu
Vascular Reactivity

Interventions

shenfu injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Estimated

Primary Completion Date

Aug 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Jul 9, 2018

First Submission Date that Met QC Criteria

Nov 20, 2018

First Posted Date

Nov 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2018

Last Update Posted Date

Nov 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianfeng Xie, physician, sponsor-investigator,clinical professor, Southeast University, ChinaSponsor-Investigator

Lead Sponsor

Jianfeng XieOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo group	Placebo Comparator	5% GS solution	Drug: shenfu injection
control group	Active Comparator	shenfu injection	Drug: shenfu injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
shenfu injection	Drug	we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock	control group placebo group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Dosage of vasoactive drugs	dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs 4/5000 dosages of adrenaline and norepinephrine

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Han

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sun qin, doc	Contact	86-15952083606		sunqin1990@126.com

Overall Officials

Name	Affiliation	Role
haibo qin, professor	southeast university zhongda hospitial	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C492793	Shen-Fu

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided