Clinical trial NCT06193980: Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness
Official title: Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ICU Acquired Weakness
Microvascular Dysfunction
Sepsis
Shock
Keywords: Exercise Limitation
ICU Survivors
Oxygen Delivery
NIRS
Microcirculation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously mechanically ventilated cohort: patients discharged from MICU and SICU

Healthy Cohort: outpatient volunteers

Brief summary: This study aims to investigate how sepsis and shock can impair 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.

Detailed description: This longitudinal study will assess microvascular function through four (4) follow-ups after ICU discharge: at (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 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. Characterize the natural trajectory of skeletal muscle microvascular function in ICU survivors using high-resolution NIRS.
2. Demonstrate an impairment in skeletal muscle microvascular oxygen delivery and cardiovascular blood flow regulation in ICU survivors.

Eligibility criteria: Inclusion Criteria:

* Patients who have received mechanical ventilation for at least 7 days in the MICU or SICU and have subsequently been discharged.
* Patients enrolled in existing microvascular monitoring study in the ICU regardless of duration of mechanical ventilation.

Exclusion Criteria:

* Unable to provide consent
* Trajectory of health expected to be significantly limited in the upcoming 12 months

Primary outcomes:
measure: Microvascular Hemoglobin Content
timeFrame: Tests will be conducted on up to four (4) different occasions after ICU discharge: (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 12 months.
measure: Vascular Occlusion Test
timeFrame: Tests will be conducted on up to four (4) different occasions after ICU discharge: (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 12 months.
measure: VO2 peak oxygen uptake
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: oxygen on/off kinetics
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: Anaerobic threshold
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: Medical Research Council (MRC) sum score
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: NIRS deoxygenation during exercise (deoxy-hemoglobin)
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: NIRS deoxygenation during exercise (tissue saturation index)
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: 6-minute walk distance
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: Forced Expiratory Volume at 1-second (FEV1)
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: Forced Vital Capacity (FVC)
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
Secondary outcomes:
measure: Functional Independence Measure (FIM) Questionnaire
timeFrame: Questionnaire will be conducted on up to four (4) different occasions after ICU discharge: (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 12 months.
measure: Frailty Index
timeFrame: Questionnaire will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: Postural Transitions
timeFrame: Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months.
measure: Recruitment and retention
timeFrame: Ongoing throughout 12 months after ICU discharge
measure: NIRS deoxygenation during handgrip (deoxy-hemoglobin)
timeFrame: Tests will be conducted on up to four (4) different occasions after ICU discharge: (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 12 months.
measure: NIRS deoxygenation during handgrip (tissue saturation index)
timeFrame: Tests will be conducted on up to four (4) different occasions after ICU discharge: (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 12 months.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre Winnipeg
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Asher Mendelson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heyland DK, Garland A, Bagshaw SM, Cook D, Rockwood K, Stelfox HT, Dodek P, Fowler RA, Turgeon AF, Burns K, Muscedere J, Kutsogiannis J, Albert M, Mehta S, Jiang X, Day AG. Recovery after critical illness in patients aged 80 years or older: a multi-center prospective observational cohort study. Intensive Care Med. 2015 Nov;41(11):1911-20. doi: 10.1007/s00134-015-4028-2. Epub 2015 Aug 26.
citation: Muscedere J, Bagshaw SM, Boyd G, Sibley S, Norman P, Day A, Hunt M, Rolfson D. The frailty, outcomes, recovery and care steps of critically ill patients (FORECAST) study: pilot study results. Intensive Care Med Exp. 2022 Jun 10;10(1):23. doi: 10.1186/s40635-022-00446-7.