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Recruiting NCT05985525

Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

— Observational Sepsis Shock Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Skeletal muscle and cerebral NIRS (research device).
Who it may be relevant to
Registry conditions: Sepsis, Shock, Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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:

1. Determine the feasibility of longitudinal NIRS monitoring in ICU patients 2. Determine the ability to derive patient-specific microvascular metrics using NIRS 3. Explore the relationship between microvascular metrics and ICU mortality

Interventions

  • Device Skeletal muscle and cerebral NIRS (research 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.

Primary outcome measures

  • Recruitment [Time frame: 30 days]
Secondary outcome measures (3)
  • protocol adherence [Time frame: 14 days]
  • NIRS and vital sign data quality [Time frame: 14 days]
  • Optimal Map (MAPopt) derivation [Time frame: 14 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Health Sciences Centre Winnipeg — Winnipeg

Identifiers

NCT: NCT05985525 · HS25043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗