NCT06360770

Brief Summary

Sepsis and septic shock are among main causes of death in patients with severe Covid-19 pneumonia. A few factors are proven to predict sepsis in these patients. WIth near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. The hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe Covid-19 pneumonia will be tested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

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

December 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

April 9, 2024

Last Update Submit

April 11, 2024

Conditions

Sepsis

Keywords

sepsismicrocirculationNIRSSarsCov19

Outcome Measures

Primary Outcomes (1)

  • sepsis development

    2 months

Secondary Outcomes (1)

  • mortality

    2 months

Eligibility Criteria

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

Critically ill patients with Covid19 pneumonia and need for ventilatory support (invasive mechanical ventilation) admitted to medical ICU of a regional general hospital.

You may qualify if:

  • Severe respiratory failure due to Covid19 pneumonia
  • Sedated, mechanically ventilated patient

You may not qualify if:

  • Sepsis with multiorgan failure present on admisssion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SB Celje

Celje, 3000, Slovenia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 11, 2024

Study Start

December 1, 2021

Primary Completion

February 28, 2023

Study Completion

April 30, 2023

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)