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

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

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:

  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.

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:
  • 5% GS solution
ACTIVE_COMPARATOR: control group
shenfu injection
we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock
Other Names:
  • 5% GS solution

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

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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