- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749525
Shenfu Injection Improves Arterial Vascular Reactivity
November 20, 2018 updated by: Jianfeng Xie
Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sun qin, doc
- Phone Number: 86-15952083606
- Email: sunqin1990@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo group
5% GS solution
|
we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock
Other Names:
|
ACTIVE_COMPARATOR: control group
shenfu injection
|
we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of peripheral vascular resistance
Time Frame: 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
|
day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diastolic blood pressure
Time Frame: day 1, day 2, day 3
|
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
Time Frame: day 1, day 2,day 3
|
dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs 4/5000 dosages of adrenaline and norepinephrine |
day 1, day 2,day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: haibo qin, professor, southeast university zhongda hospitial
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2018
Primary Completion (ANTICIPATED)
August 1, 2019
Study Completion (ANTICIPATED)
September 1, 2019
Study Registration Dates
First Submitted
July 9, 2018
First Submitted That Met QC Criteria
November 20, 2018
First Posted (ACTUAL)
November 21, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2018
Last Update Submitted That Met QC Criteria
November 20, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- shenfu injection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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