SepsisMiMICSSNCT05985525
Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)
An observational study of Sepsis and Shock, run by University of Manitoba at 1 site in Canada.
Trial summary
Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Shock, Critical Illness
- What is being tested?
- Skeletal muscle and cerebral NIRS (research device)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2022to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults admitted to the ICU receiving invasive mechanical ventilation
Who may be able to join
- Admitted to ICU
- Receiving invasive mechanical ventilation
Who cannot join
- Body Mass Index >40
- More than 24 hours has elapsed since ICU admission
- Death is deemed to be imminent and inevitable during the next 24 hours
- Known allergy to the textile components of the device
- Significant clinical jaundice, ecchymosis
- COVID positive microbiological result
- The treating clinician believes that participation in the domain would not be in the best interests of the patient
- Consent declined from patient or authorized third party
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
Asher Mendelson, MD PhD, 2047871634, asher.mendelson@umanitoba.ca
Frederick Zeiler, MD PhD
About this study
Official title: Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS): Prospective Observational Cohort Study
Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.
Read the detailed description
This is a prospective observational study using non-invasive NIRS for microvascular monitoring in the ICU. The study involves no interventions above standard of care other than the application of the NIRS monitors.
NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU admission. Vital signs are extracted continuously from the ICU monitor and clinical data are recorded from patient records.
The broad goals of the study are:
- Determine the feasibility of longitudinal NIRS monitoring in ICU patients
- Determine the ability to derive patient-specific microvascular metrics using NIRS
- Explore the relationship between microvascular metrics and ICU mortality
- Conditions
- Sepsis, Shock, Critical Illness
- Being tested
- Skeletal muscle and cerebral NIRS (research device)
- Keywords
- Near-Infrared Spectroscopy
- Medical subject headings
- Sepsis, Shock, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal muscle and cerebral NIRS (research device)Device
Also called PortaMon (Artinis Inc, Netherlands), PortaLite (Artinis Inc, Netherlands)
NIRS applied on skeletal muscle and brain on days 1, 3, and 8 of ICU admission. Monitoring applied for up to 24hrs on each day.
| Study group | Role | What they receive |
|---|---|---|
| Observational | All patients Receives: Device: Skeletal muscle and cerebral NIRS (research device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment of two patients per month from each study site
Measured: 30 days
Secondary outcomes (3)
protocol adherence
collection of NIRS and clinical data for each monitoring session
Measured: 14 days
NIRS and vital sign data quality
NIRS and vital sign data is >50% free of artifacts for >80% of recording sessions to enable further analysis
Measured: 14 days
Optimal Map (MAPopt) derivation
when MAP and NIRS data available together, ability to derive MAPopt from >80% of recording sessions using correlation analysis
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start27 May 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
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.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asher Mendelson, University of Manitoba
- Investigators
- Asher Mendelson, MD, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985525
- Sponsor's protocol ID
- HS25043
- Acronym
- MiMICSS
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2023
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS): Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05985525
- Acronym / sponsor ID
- MiMICSS / HS25043
- Conditions
- Sepsis, Shock, Critical Illness
- Keywords
- Near-Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.
Detailed description
This is a prospective observational study using non-invasive NIRS for microvascular monitoring in the ICU. The study involves no interventions above standard of care other than the application of the NIRS monitors.
NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU admission. Vital signs are extracted continuously from the ICU monitor and clinical data are recorded from patient records.
The broad goals of the study are:
- Determine the feasibility of longitudinal NIRS monitoring in ICU patients
- Determine the ability to derive patient-specific microvascular metrics using NIRS
- Explore the relationship between microvascular metrics and ICU mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Device: Skeletal muscle and cerebral NIRS (research device)All patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the ICU receiving invasive mechanical ventilation
Key inclusion criteria (2 listed)
- Admitted to ICU
- Receiving invasive mechanical ventilation
Key exclusion criteria (8 listed)
- Body Mass Index >40
- More than 24 hours has elapsed since ICU admission
- Death is deemed to be imminent and inevitable during the next 24 hours
- Known allergy to the textile components of the device
- Significant clinical jaundice, ecchymosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skeletal muscle and cerebral NIRS (research device)Also: PortaMon (Artinis Inc, Netherlands), PortaLite (Artinis Inc, Netherlands)NIRS applied on skeletal muscle and brain on days 1, 3, and 8 of ICU admission. Monitoring applied for up to 24hrs on each day. | Device | Observational |
Primary outcome
Recruitment
Time frame: 30 days
Recruitment of two patients per month from each study site
3 secondary outcomes
protocol adherence
Time frame: 14 days
NIRS and vital sign data quality
Time frame: 14 days
Optimal Map (MAPopt) derivation
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Asher Mendelson, MD, PhD principal investigator
University of Manitoba
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 and Shock, run by University of Manitoba at 1 site in Canada.
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 8 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asher Mendelson, MD, PhD (2047871634, asher.mendelson@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 30 days). 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 24 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.