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ICU Combined Assessment of Cardio-Respiratory Exercise (ICU-CARE)

U

University of Manitoba

Status

Enrolling

Conditions

Shock
Critical Illness
ICU Acquired Weakness
Microcirculation
Sepsis

Study type

Observational

Funder types

Other

Identifiers

NCT06193980
HS25592

Details and patient eligibility

About

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.

Full description

This longitudinal study will assess cardiovascular fitness and microvascular function through two (2) follow-ups after ICU discharge: at (i) 6 months, and (ii) 12 months. The goal is to understand how microvascular dysfunction contributes to ICU-AW and long-term exercise limitation in ICU survivors.

Specific goals are:

  1. Evaluate peak oxygen uptake and oxygen on/off kinetics in ICU survivors using a standardized cardiopulmonary exercise test (CPET) protocol.
  2. Characterize skeletal muscle microvascular function in ICU survivors using high-resolution NIRS during CPET protocol.
  3. Determine the association between impairments in skeletal muscle microvascular oxygen delivery and cardiovascular blood flow regulation in ICU survivors.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 Winnipeg

Trial design

50 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Asher Mendelson, MD PhD

Data sourced from clinicaltrials.gov

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