Back to resultsComparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
Primary Purpose
Sepsis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sublingual microcirculation,
hemodynamic monitoring
Sponsored by
About this trial
This is an interventional other trial for Sepsis focused on measuring Septic shock; Sublingual Microcirculation
Eligibility Criteria
Inclusion Criteria:
- patients fulfilled the diagnostic criteria of septic shock.
Exclusion Criteria:
- declined to participate
- pregnant
- patients who were younger than 18 years old
- active bleeding
- septic shock is diagnosed for more than 4 hours
- patients are expected to be die within 24hours
Sites / Locations
- Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Microcirculation-oriented resuscitation group
Control group
Arm Description
The microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%).
The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.
Outcomes
Primary Outcome Measures
change in SOFA score
△SOFA
Secondary Outcome Measures
30-day mortality
mortality
Full Information
NCT ID
NCT05118646
First Posted
November 1, 2021
Last Updated
November 1, 2021
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05118646
Brief Title
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
Official Title
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Early Fluid Resuscitation in Patients With Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
Detailed Description
Objectives: Comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock.
Intervention:
Microcirculation-oriented resuscitation group: When the system hemodynamics meets the standard of EDGT, the microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%).
Control group: The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.
Primary outcome:
(1)change in SOFA score at 72h (2)30-day mortality
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Septic shock; Sublingual Microcirculation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microcirculation-oriented resuscitation group
Arm Type
Experimental
Arm Description
The microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%).
Arm Title
Control group
Arm Type
Other
Arm Description
The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.
Intervention Type
Device
Intervention Name(s)
sublingual microcirculation,
Intervention Description
Avoiding pressure artifacts, clear stable microvascular images were taken for a minimum of 20 seconds of the left, middle, and right sections of the tongue.
Intervention Type
Device
Intervention Name(s)
hemodynamic monitoring
Intervention Description
Arterial blood lactic acid (Lac), central venous oxygen saturation (ScvO2), hematocrit (HCT) and entral venous-to-arterial carbon dioxide partial pressure difference (Pcv-aCO2) will be measured employing a bedside blood gas machine on admission and six hours following admission.
Primary Outcome Measure Information:
Title
change in SOFA score
Description
△SOFA
Time Frame
72h
Secondary Outcome Measure Information:
Title
30-day mortality
Description
mortality
Time Frame
30d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients fulfilled the diagnostic criteria of septic shock.
Exclusion Criteria:
declined to participate
pregnant
patients who were younger than 18 years old
active bleeding
septic shock is diagnosed for more than 4 hours
patients are expected to be die within 24hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Zhang, MD.
Phone
+8615874875763
Email
zln7095@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lina Zhang, MD.
Organizational Affiliation
XiangYa Hospital CentralSouth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Zhang
12. IPD Sharing Statement
Learn more about this trial
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
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