NCT07404475

Brief Summary

Sepsis-induced coagulopathy (SIC) and microvascular dysfunction are hallmark features of sepsis, yet their longitudinal relationship remains poorly understood. The aim of this study is to investigate the interplay between sublingual microcirculation, endothelial damage, peripheral tissue oxygenation and coagulation parameters in patients with sepsis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

SepsisCoagulopathy

Keywords

sepsismicrocirculationtissue oxygenationcoagulopathyglycocalyx

Outcome Measures

Primary Outcomes (1)

  • Perfused vessel density

    difference between patients with sepsis induced coagulopathy and patients without coagulopathy

    day 0 (on enrollment)

Secondary Outcomes (1)

  • variations in microvascular parameters

    day 0 to day 4 (96 hours)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients with sepsis or septic shock admitted to a 14-bed medical Intensive Care Unit

You may qualify if:

  • adult (\>18 years of age)
  • sepsis or septic shock

You may not qualify if:

  • sepsis for more than 24 hours
  • pre-existing coagulopathy
  • concurrent use of therapeutic anticoagulation or thrombolytic agents
  • factors impeding the sublingual microvascular assessment
  • pregnancy
  • inability to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria delle Marche

Ancona, 60126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Conditions

SepsisHemostatic Disorders

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

June 1, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)