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

NCT05118646 | Unknown

• 1 other identifier: 202006141
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis

Keywords

Septic shock; Sublingual Microcirculation

Outcome Measures

Primary Outcomes (1)

• change in SOFA score

  △SOFA

  72h

Secondary Outcomes (1)

• 30-day mortality

  30d

Study Arms (2)

Microcirculation-oriented resuscitation group

EXPERIMENTAL

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,; Device: hemodynamic monitoring

Control group

OTHER

The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.

Device: hemodynamic monitoring

Interventions

sublingual microcirculation, DEVICE

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.

Microcirculation-oriented resuscitation group

hemodynamic monitoring DEVICE

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.

Control group; Microcirculation-oriented resuscitation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients fulfilled the diagnostic criteria of septic shock.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Hemodynamic Monitoring

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• lina Zhang, MD.

  XiangYa Hospital CentralSouth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Zhang, MD.

CONTACT

+8615874875763; zln7095@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 12, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: November 12, 2021

Record last verified: 2020-12

Locations

CN (1)