Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia
Assessement of Microcirculation With NIRS Predicts Sepsis Development in Mechanically Ventilated Patients With Severe Covid-19 Pneumonia
Study Overview
Status
Conditions
Detailed Description
At the moment the majority of ICU admissions in Slovenia are due to severe Covid19 pneumonia. Despite intensive supportive treatment the mortality of these patients is high, around 30%. The main reason for ICU admission is respiratory failure, these patients usually do not have multiorgan failure on admisssion. In the early phase of disease the inflamatory, endothelial and microcirculatory response is different than that in "classic" septic shock. One of the most common complications later in the course of severe Covid19 pneumonia is sepsis, which is defined as a life threatening syndrome with the failure of one or more organs due to disregulated inflamatory host response. This definition can be connected to the majority of patients who die.
It is not well known which factors predict sepsis development in patients with severe Covid19 pneumnia. In a laboratory mode the coagulation abnormality have been shown to be one of them. One of the earliest features of sepsis are microcirculation dysfunction and oxygene consumption abnormalities. Many studies have shown that with near infrared spectroscopy, we can reliably assess these abnormalities. With this method the tissue oxygene saturation can be measured. With vasoocclusive test the rate of tissue deoxygenation during stagnant ischemia and the rate of reoxygenation after flow release can be determined. It has been shown that the inclination of both curves decreases in sepsis. The measurements have also prognostic value.
With the clinical study we want to detect the microcirculatory abnormalities, typical for sepsis, early in the course, before the clinical and laboratory signs of multiorgan failure develop.
Aim of the study is to test hypotheis that NIRS measurements can predict sepsis development early and that machanically ventilated (due to Covid 19 pneumonia) patients with microcirculatory abnormalities have worse prognosis than those with preserved microcirculatory function.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Celje, Slovenia, 3000
- SB Celje
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Severe respiratory failure due to Covid19 pneumonia
- Sedated, mechanically ventilated patient
Exclusion Criteria:
- Sepsis with multiorgan failure present on admisssion
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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sepsis development
Time Frame: 2 months
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2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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mortality
Time Frame: 2 months
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2 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIRSCovidSBCelje
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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