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
About this trial
This is an interventional treatment trial for Septic Shock
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.
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
NCT ID
NCT04136080
First Posted
October 21, 2019
Last Updated
October 21, 2019
Sponsor
Fujian Provincial Hospital
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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