An observational study in ICU Acquired Weakness, Sepsis and Shock, sponsored by University of Manitoba. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University of Manitoba · Observational
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.
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 first timepoint will be at 6 months will be required, and the second timepoint at 12 months will be optional based on participant availability. The goal is to understand how microvascular dysfunction contributes to ICU-AW and long-term exercise limitation in ICU survivors.
Specific goals are:
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
ICU survivor: Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have received prolonged mechanical ventilation (7 days or more) in the intensive care unit (ICU), and have been discharged from hospital.
Rate of enrollment
Rate of participant enrollment in the study will be recorded. Feasibility of enrollment will be one participant per month.
Time frame: 6 months after ICU discharge
Protocol completion
The number of completed sessions within 12 months for each eligible patient will be recorded. Feasibility target will be ≥ 80% completion of the protocol at 6 month time point for all participants.
Time frame: Ongoing throughout 12 months after ICU discharge
VO2 peak oxygen uptake
Peak Oxygen uptake (VO2, mL/kg/min) will be measured during incremental exercise on a cycle ergometer during cardiopulmonary exercise testing (CPET).
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 constant (seconds) of oxygen uptake will be assessed at the transition to constant work rate exercise at the beginning of CPET; time constant (seconds) of oxygen uptake will also be assessed at the transition to rest at the end of CPET after reaching VO2 peak.
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)
NIRS will be applied to the vastus lateralis during exercise testing. Deoxygenation profile, as measured by increase in deoxy-hemoglobin will be recorded throughout exercise. Higher values indicate impaired oxygen delivery to tissue.
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)
NIRS will be applied to the vastus lateralis during exercise testing. Deoxygenation profile, as measured by decrease in tissue saturation index will be recorded throughout exercise. Lower values indicate impaired oxygen delivery to tissue.
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Functional Independence Measure (FIM) Questionnaire
will assess functional capacity, and will be administered by research staff. Response will be sought directly from the patient. FIM is scored with motor (13-91) and cognitive (5-35). Lower scores indicate lower functional independence
Time frame: Questionnaire will be conducted on up to 2 (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Frailty Index
The frailty index identifies 42 deficits, each coded as 0 (absent), 1 (present), or 0.5 (where intermediate values were possible). It was calculated as the cumulative proportion of deficits present (minimum score 0; maximum score 1.0), and then graded as mild (0 and 0.2), moderate (0.2 and 0.4) or severe frailty (\>0.4). See references for studies where Index is derived.
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Medical Research Council (MRC) sum score
Medical Research Council (MRC) sum score tests power in muscle groups for upper and lower extremities and score is tallied as the sum of all tested muscles. Value ranges from complete paralysis (0/60) to full strength (60/60). Score less than 48/60 denotes clinically significant weakness.
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Anaerobic threshold
Work rate at anaerobic threshold (AT), represented at percentage of VO2 peak will be quantified with CPET. This corresponds to the time where oxygen (O2) utilization and carbon dioxide (CO2) production curves begin to diverge.
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Forced Vital Capacity (FVC)
Standard spirometry techniques are used to quantify the maximum volume of expired breath (Litres), and represented as a %predicted compared to reference values. All tests are performed in accordance with standard ATS guidelines.
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Forced Expiratory Volume at 1-second (FEV1)
Standard spirometry techniques are used to quantify the volume of expired breath (Litres) in 1 second, and represented as a %predicted compared to reference values. All tests are performed in accordance with standard ATS guidelines.
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Plan to share: No
Started Dec 2023 (actual). Primary completion is estimated for Dec 2029, 72 months after the start.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 72 months is above that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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