SepsisNCT03859726
Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring
An observational study of Sepsis, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Change and predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- NIRS and Sublingual microcirculation
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)．
Who may be able to join
- patients fullfilled the diagnostic criteria of Sepsis 3.0
Who cannot join
- Patients who were younger than 18 years old，
- pregnant women
- patients who had been admitted to the Intensive Care Unit(ICU for<24 h)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation
Change and predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation
Read the 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.
- Conditions
- Sepsis
- Being tested
- NIRS, Sublingual microcirculation
- Keywords
- Sepsis, NIRS, sublingual microcirculation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDiagnostic test
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.
Sublingual microcirculationDiagnostic test
The sidestream dark field (SDF) imaging devices provide high contrast images of the microvasculature.
| Study group | Role | What they receive |
|---|---|---|
| Compliance group | 6hLC≥10% NIRS Sublingual microcirculation Receives: Diagnostic Test: NIRS; Diagnostic Test: Sublingual microcirculation | |
| Non compliance group | 6hLC<10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis Related Organ Failure Assessment
SOFA
Measured: 72 hours
Secondary outcomes (1)
28-day mortality
mortality
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start20 Mar 2019
- Primary completion31 Mar 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859726
- Sponsor's protocol ID
- 201902035
- Status last verified
- Jan 2019
- First submitted
- 28 Feb 2019
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41031817
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation
- ClinicalTrials.gov ID
- NCT03859726
- Acronym / sponsor ID
- 201902035
- Conditions
- Sepsis
- Keywords
- Sepsis, NIRS, sublingual microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliance group | – | Diagnostic Test: NIRS, Diagnostic Test: Sublingual microcirculation6hLC≥10% NIRS Sublingual microcirculation |
| Non compliance group | – | –6hLC<10% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)．
Key inclusion criteria (1 listed)
- patients fullfilled the diagnostic criteria of Sepsis 3.0
Key exclusion criteria (3 listed)
- Patients who were younger than 18 years old，
- pregnant women
- patients who had been admitted to the Intensive Care Unit(ICU for<24 h)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSNear-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 | Compliance group |
| Sublingual microcirculationThe sidestream dark field (SDF) imaging devices provide high contrast images of the microvasculature. | Diagnostic test | Compliance group |
Primary outcome
Sepsis Related Organ Failure Assessment
Time frame: 72 hours
SOFA
1 secondary outcome
28-day mortality
Time frame: 28-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Derived from this study: PubMed 41031817Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis Related Organ Failure Assessment (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03859726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.