SepsisNCT06360770
Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia
An observational study of Sepsis, run by General and Teaching Hospital Celje at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 35 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2021to 30 Apr 2023
- 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: Critically ill patients with Covid19 pneumonia and need for ventilatory support (invasive mechanical ventilation) admitted to medical ICU of a regional general hospital.
Who may be able to join
- Severe respiratory failure due to Covid19 pneumonia
- Sedated, mechanically ventilated patient
Who cannot join
- Sepsis with multiorgan failure present on admisssion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessement of Microcirculation With NIRS Predicts Sepsis Development in Mechanically Ventilated Patients With Severe Covid-19 Pneumonia
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.
Read the 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.
- Conditions
- Sepsis
- Keywords
- sepsis, microcirculation, NIRS, SarsCov19
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
sepsis development
Measured: 2 months
Secondary outcomes (1)
mortality
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Dec 2021
- Primary completion28 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- General and Teaching Hospital Celje
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Podbregar, General and Teaching Hospital Celje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360770
- Sponsor's protocol ID
- NIRSCovidSBCelje
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessement of Microcirculation With NIRS Predicts Sepsis Development in Mechanically Ventilated Patients With Severe Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT06360770
- Acronym / sponsor ID
- NIRSCovidSBCelje
- Conditions
- Sepsis
- Keywords
- sepsis, microcirculation, NIRS, SarsCov19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- General and Teaching Hospital CeljeUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Apr 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Severe respiratory failure due to Covid19 pneumonia
- Sedated, mechanically ventilated patient
Key exclusion criteria (1 listed)
- Sepsis with multiorgan failure present on admisssion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sepsis development
Time frame: 2 months
1 secondary outcome
mortality
Time frame: 2 months
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 12 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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 General and Teaching Hospital Celje at 1 site in Slovenia.
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 2 inclusion and 1 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 12 Apr 2024. 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 Slovenia. 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 development (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.