Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock

Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Early Fluid Resuscitation in Patients With Septic Shock

Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Device: sublingual microcirculation,; Device: hemodynamic monitoring

Detailed Description

Objectives: Comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock.

Intervention:

1. 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%).
2. 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

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Zhang, MD.; Phone Number: +8615874875763; Email: zln7095@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Lina Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microcirculation-oriented resuscitation group; The microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%).	Device: sublingual microcirculation,; 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.; Device: hemodynamic monitoring; 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.
Other: Control group; The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.	Device: hemodynamic monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in SOFA score	△SOFA	72h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	mortality	30d

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: lina Zhang, MD., XiangYa Hospital CentralSouth University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Septic shock; Sublingual Microcirculation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: 202006141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No