Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring

Sponsor

Xiangya Hospital of Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT03859726

Collaborator

(none)

Enrollment

Location

12.4

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Mar 20, 2019

Actual Primary Completion Date :

Mar 31, 2019

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	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%

Arm

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%

Outcome Measures

Primary Outcome Measures

Sepsis Related Organ Failure Assessment [72 hours]
SOFA

Secondary Outcome Measures

28-day mortality [28-day]
mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangya Hospital, Central South University	Changsha	Hunan	China	410000

Sponsors and Collaborators

Xiangya Hospital of Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiangya Hospital of Central South University

ClinicalTrials.gov Identifier:

NCT03859726

Other Study ID Numbers:

201902035

First Posted:

Mar 1, 2019

Last Update Posted:

Jul 27, 2020

Last Verified:

Jan 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiangya Hospital of Central South University

Sepsis, NIRS, sublingual microcirculation

Additional relevant MeSH terms:

Sepsis

Study Results

No Results Posted as of Jul 27, 2020