search
Back to results

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
Jianfeng Xie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    July 9, 2018
    Last Updated
    November 20, 2018
    Sponsor
    Jianfeng Xie
    search

    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

    Learn more about this trial

    Shenfu Injection Improves Arterial Vascular Reactivity

    We'll reach out to this number within 24 hrs