Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring

Completed

• Conditions: Sepsis
• Interventions: Diagnostic Test: NIRS; Diagnostic Test: Sublingual microcirculation

• Registration Number: NCT03859726
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Study Start: 2019-03-20
• Primary Completion: 2019-03-31
• Study Completion: 2020-03-31
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Compliance group	NIRS	6hLC≥10% NIRS Sublingual microcirculation
Compliance group	Sublingual microcirculation	6hLC≥10% NIRS Sublingual microcirculation

Primary Outcome Measures

Name	Time	Method
Sepsis Related Organ Failure Assessment	72 hours	SOFA

Secondary Outcome Measures

Name	Time	Method
28-day mortality	28-day	mortality

Trial Locations

Locations (1)

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China