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The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vasopressors
Sponsored by
Fujian Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
Adult patients (≥18 years) admitted to The Critical Medicine Departments Three of Fujian Provincial Hospital will be considered eligible,who are presence of infection or suspected infection,requiring mechanical ventilation. At the same time, without the vasopressors the MAP would be less than 65mmHg, and the blood lactic acid level is higher than 2mmol/l.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    chronic hypertension group

    denying chronic hypertension group

    Arm Description

    septic patients with chronic hypertension

    septic patients without chronic hypertension

    Outcomes

    Primary Outcome Measures

    the 28-day all-cause mortality and Changes of sublingual microcirculation
    the 28-day all-cause mortality and Changes of sublingual microcirculation

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2019
    Last Updated
    October 21, 2019
    Sponsor
    Fujian Provincial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04136080
    Brief Title
    The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock
    Official Title
    The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    January 30, 2021 (Anticipated)
    Study Completion Date
    November 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fujian Provincial Hospital

    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
    Background: The mean arterial pressure( MAP) is a key pressure index to improve tissue perfusion. At present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. The changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. Purpose: This study is mean to increase the MAP in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. Method: This is a single-center, randomized, prospective cohort study. Eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. These patients will be treat with vasopressors to maintain MAP at 90±5 mmHg and 70±5 mmHg. Outcome: The 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the Changes of sublingual microcirculation, SOFA, APACHE-Ⅱ score Will be recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    752 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    chronic hypertension group
    Arm Type
    Other
    Arm Description
    septic patients with chronic hypertension
    Arm Title
    denying chronic hypertension group
    Arm Type
    Other
    Arm Description
    septic patients without chronic hypertension
    Intervention Type
    Other
    Intervention Name(s)
    vasopressors
    Intervention Description
    control the mean arterial pressure with vasopressors
    Primary Outcome Measure Information:
    Title
    the 28-day all-cause mortality and Changes of sublingual microcirculation
    Description
    the 28-day all-cause mortality and Changes of sublingual microcirculation
    Time Frame
    28 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Adult patients (≥18 years) admitted to The Critical Medicine Departments Three of Fujian Provincial Hospital will be considered eligible,who are presence of infection or suspected infection,requiring mechanical ventilation. At the same time, without the vasopressors the MAP would be less than 65mmHg, and the blood lactic acid level is higher than 2mmol/l.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    shang xiuling, Phd
    Phone
    13763895158
    Email
    zksxling@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

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