Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring
1 other identifier
observational
72
1 country
1
Brief Summary
Change and predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJuly 27, 2020
January 1, 2019
11 days
February 28, 2019
July 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sepsis Related Organ Failure Assessment
SOFA
72 hours
Secondary Outcomes (1)
28-day mortality
28-day
Study Arms (2)
Compliance group
6hLC≥10% NIRS Sublingual microcirculation
Non compliance group
6hLC\<10%
Interventions
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.
The sidestream dark field (SDF) imaging devices provide high contrast images of the microvasculature.
Eligibility Criteria
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)．
You may qualify if:
- patients fullfilled the diagnostic criteria of Sepsis 3.0
You may not qualify if:
- Patients who were younger than 18 years old，
- pregnant women
- patients who had been admitted to the Intensive Care Unit(ICU for\<24 h)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital, Central South University
Changsha, Hunan, 410000, China
Related Publications (1)
Zhang X, Zhang H, Jin R, Li L, Huang L, Wang Z, Peng Q, Ai M, Zhang L. Assessment of Sublingual Microcirculation to Evaluate the Efficacy of Resuscitation Therapy in Septic Shock Patients: A Cohort Study. Shock. 2026 Feb 1;65(2):161-172. doi: 10.1097/SHK.0000000000002708. Epub 2025 Sep 25.
PMID: 41031817DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2019
First Posted
March 1, 2019
Study Start
March 20, 2019
Primary Completion
March 31, 2019
Study Completion
March 31, 2020
Last Updated
July 27, 2020
Record last verified: 2019-01