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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118646
• Other study ID #: 202006141
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2020
• Source: Xiangya Hospital of Central South University
• Contact: Lina Zhang, MD.
• Phone: +8615874875763
• Email: zln7095[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Shock, Septic

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in SOFA score	?SOFA	72h
Secondary	30-day mortality	mortality	30d