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Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859726
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
Change and predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation

Condition or disease Intervention/treatment
Sepsis Diagnostic Test: NIRS Diagnostic Test: Sublingual microcirculation

Detailed Description:

Fluid therapy for sepsis patients has always been a research hotspot. Early studies suggest that early goal-directed therapy (EGDT) can reduce mortality in patients with sepsis and septic shock, which is included in the guidelines. However, recent studies suggest that EGDT does not reduce mortality. This may be related to the fact that EGDT only pays attention to systemic circulation and neglects microcirculation.

In the past few decades, arterial blood pressure, blood lactic acid and other circulatory indicators have been the target of septic shock treatment, but normal systemic circulation does not mean normal tissue perfusion. Obstacles to tissue perfusion, oxygenation and microcirculation may still exist. At the same time, compared with systemic hemodynamic parameters, microcirculation parameters may play a stronger role in predicting the prognosis of sepsis patients. It is believed that the ideal goal of resuscitation therapy for sepsis should be based on whether microcirculation function has been restored or not.

Objective:to observe the success rate of microcirculation imaging and oxygen saturation of peripheral tissues in sepsis patients under the guidance of current guidelines and procedures. At the same time, we compared the predictive value of microcirculation indicators to the prognosis of septic shock patients.

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Compliance group
6hLC≥10% NIRS Sublingual microcirculation
Diagnostic Test: NIRS
Near-infrared spectroscopy (NIRS) offers non-invasive, in-vivo, real-time monitoring of tissue oxygenation. Changes in regional tissue oxygenation as detected by NIRS may reflect the delicate balance between oxygen delivery and consumption.

Diagnostic Test: Sublingual microcirculation
The sidestream dark field (SDF) imaging devices provide high contrast images of the microvasculature.

Non compliance group
6hLC<10%



Primary Outcome Measures :
  1. Sepsis Related Organ Failure Assessment [ Time Frame: 72 hours ]
    SOFA


Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28-day ]
    mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Results for continuous variables with normal distributions were presented as mean±standard deviations (SD).Results for continuous variables that were not normally distributed were presented as median(Ql,Q1).
Criteria

Inclusion Criteria:

  • patients fullfilled the diagnostic criteria of Sepsis 3.0

Exclusion Criteria:

  • Patients who were younger than 18 years old,
  • pregnant women
  • patients who had been admitted to the Intensive Care Unit(ICU for<24 h)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859726


Locations
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China, Hunan
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410000
Sponsors and Collaborators
Xiangya Hospital of Central South University
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03859726    
Other Study ID Numbers: 201902035
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
Sepsis, NIRS, sublingual microcirculation
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes