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

NCT ID: NCT05118646

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-30

Brief Summary

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

Detailed Description

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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

Conditions

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Sepsis

Keywords

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Septic shock; Sublingual Microcirculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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%).

Group Type EXPERIMENTAL

sublingual microcirculation,

Intervention Type 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.

hemodynamic monitoring

Intervention Type 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

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

Group Type OTHER

hemodynamic monitoring

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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lina Zhang, MD.

Role: PRINCIPAL_INVESTIGATOR

XiangYa Hospital CentralSouth University

Locations

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Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lina Zhang, MD.

Role: CONTACT

Phone: +8615874875763

Email: [email protected]

Facility Contacts

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Lina Zhang

Role: primary

Other Identifiers

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202006141

Identifier Type: -

Identifier Source: org_study_id