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NCT Number: NCT05985525

Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

Location status: Recruiting

Location contact

Asher Mendelson, MD PhD

CONTACT

[email protected]

2047871634

Frederick Zeiler, MD PhD

SUB_INVESTIGATOR

Ryan Zarychanski, MD MSc

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admitted to ICU
  • Receiving invasive mechanical ventilation

Exclusion criteria

  • 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

Treatment and study plan

Skeletal muscle and cerebral NIRS (research device)

Device

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.

Other names: PortaMon (Artinis Inc, Netherlands), PortaLite (Artinis Inc, Netherlands)

Primary outcomes

  1. Recruitment

    Time frame: 30 days

    Recruitment of two patients per month from each study site

Secondary outcomes

  1. protocol adherence

    Time frame: 14 days

    collection of NIRS and clinical data for each monitoring session

  2. NIRS and vital sign data quality

    Time frame: 14 days

    NIRS and vital sign data is >50% free of artifacts for >80% of recording sessions to enable further analysis

  3. Optimal Map (MAPopt) derivation

    Time frame: 14 days

    when MAP and NIRS data available together, ability to derive MAPopt from >80% of recording sessions using correlation analysis

Other outcomes

  1. ICU mortality

    Time frame: 30 days

    ICU mortality status

  2. Hospital mortality

    Time frame: 100 days

    Hospital mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Asher Mendelson, MD, PhD

CONTACT

[email protected]

2047871634

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS): Prospective Observational Cohort Study

Acronym: MiMICSS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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