Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

Sepsis Clinical Trial

— MiMICSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985525
• Other study ID #: HS25043
• Status: Recruiting
• Start date: May 27, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: August 2023
• Source: University of Manitoba
• Contact: Asher Mendelson, MD, PhD
• Phone: 2047871634
• Email: asher.mendelson[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Sepsis
• Shock
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
Canada	Health Sciences Centre Winnipeg	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU mortality	ICU mortality status	30 days
Other	Hospital mortality	Hospital mortality	100 days
Primary	Recruitment	Recruitment of two patients per month from each study site	30 days
Secondary	protocol adherence	collection of NIRS and clinical data for each monitoring session	14 days
Secondary	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	14 days
Secondary	Optimal Map (MAPopt) derivation	when MAP and NIRS data available together, ability to derive MAPopt from >80% of recording sessions using correlation analysis	14 days