Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT06193980

Conditions

ICU Acquired Weakness

Sepsis

Shock

Critical Illness

Microcirculation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study aims to investigate how sepsis and critical illness can impair the cardiovascular system and microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.

Conditions

ICU Acquired Weakness

Sepsis

Shock

Critical Illness

Microcirculation

Study ID

NCT06193980

Start date

Dec 15, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital.

Exclusion Criteria:

  • Unable to provide consent
  • Trajectory of health expected to be significantly limited in the upcoming 12 months
  • those who self-report that they cannot climb at least one flight of stairs due to limited exercise capacity
  • have significant orthopedic or musculoskeletal impairment affecting mobility
  • have a medical history of neuromuscular disease
  • ongoing respiratory limitations (i.e., supplemental oxygen)
  • significant heart disease (i.e. ejection fraction less than 30%, unstable ischemic heart disease, severe valvular heart disease)
  • a body mass index (BMI) of ≥ 40 kg/m2 (impacting NIRS signal due to adipose tissue thickness)
  • if participant's primary residence is a significant distance from the participating study site

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

ICU survivors

Patients who have received prolonged mechanical ventilation (7 days or more) in the intensive care unit (ICU), and have been discharged from hospital.

Primary outcome measure

  • Rate of enrollment [ Time Frame: 6 months after ICU discharge ]
  • Protocol completion [ Time Frame: Ongoing throughout 12 months after ICU discharge ]
  • VO2 peak oxygen uptake [ Time Frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months. ]
  • oxygen on/off kinetics [ Time Frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months. ]
  • NIRS deoxygenation during exercise (deoxy-hemoglobin) [ Time Frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months. ]
  • NIRS deoxygenation during exercise (tissue saturation index) [ Time Frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months. ]

Central Contacts and Locations

Central contacts

Asher Mendelson, MD PhD

204-787-1634Asher.Mendelson@umanitoba.ca

Locations

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Asher Mendelson, MD PhD

204-787-1634asher.mendelson@umanitoba.ca

Health Sciences Centre Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Asher Mendelson, MD PhD

204-787-1634asher.mendelson@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • ICU Survivors
  • Oxygen Delivery
  • Microcirculation
  • skeletal muscle
  • Exercise
  • near-infrared spectroscopy
  • cardiopulmonary exercise test
  • cardiovascular physiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-06-15.