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Correlation between sublingual microcirculatory dysfunction and coagulation-fibrinolysis markers and their prognostic value in sepsis: A prospective observational study

Correlation between sublingual microcirculatory dysfunction and coagulation-fibrinolysis markers and their prognostic value in sepsis: A prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121496
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Sepsis Cohort:None (observational prospective cohort study, only recording natural course and standard treatment)

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old; 2.Definite diagnosis of sepsis, meeting the Sepsis-3.0 criteria: presence of confirmed infection (infection site such as lung, abdominal cavity, urinary system, etc. must be verified by clinical, laboratory or imaging evidence), and Sequential Organ Failure Assessment (SOFA) score >= 2 points; 3.Time interval from sepsis onset to ICU admission = 3 months, and the current sepsis episode is not directly related to previous episodes. 5.No anticoagulant/antiplatelet/thrombolytic therapy received within 72 hours before the confirmed diagnosis of sepsis; 6.Baseline data collection can be completed within 24 hours after ICU admission; 7.Expected survival time >= 72 hours; 8.Written informed consent signed by the patient or his/her legal representative.

Exclusion criteria

Exclusion criteria: 1.Patients with non-first diagnosis of sepsis who do not meet the 4th inclusion criterion; 2.The current sepsis episode is a recurrence (defined as being caused by the same infection source/pathogen as the previous sepsis episode, or the time interval from clinical cure of previous sepsis is 24 hours, or the onset time cannot be clearly traced; 5.Complicated with congenital coagulation disorders (e.g., hemophilia) or severe chronic liver failure (Child-Pugh grade C or above); complicated with end-stage diseases: e.g., advanced malignant tumor (expected survival time < 6 months), end-stage renal disease requiring long-term dialysis with expected survival time < 6 months; 6.Complicated with oral diseases or limited by conditions that prevent sublingual microcirculation detection (e.g., severe oral infection, massive oral hemorrhage, post-oral surgery); 7.Pregnant or lactating women; 8.Refuse or are unable to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
All-cause mortality at 28 days;

Secondary

MeasureTime frame
Microcirculatory functional recovery rate within 72 hours after admission;Dynamic expression profile of coagulation-fibrinolysis biomarkers;Change in microcirculatory parameters within 72 hours after admission;Correlation between coagulation biomarkers and microcirculatory parameters;Duration of ICU stay;Incidence of multiple organ failure (MOF);Performance of integrated coagulation-fibrinolysis biomarker prediction model;

Countries

China

Contacts

Public ContactYang Chunhua

The Sixth Affiliated Hospital, Sun Yat-sen University

yangchunhua_gd@126.com+86 136 0272 8896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026