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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of enrollment | Rate of participant enrollment in the study will be recorded. Feasibility of enrollment will be one participant per month. | 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. | 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). | 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Questionnaire will be conducted on up to 2 (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asher Mendelson, MD PhD | Contact | 204-787-1634 | Asher.Mendelson@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Asher Mendelson, MD PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface General Hospital | Recruiting | Winnipeg | Manitoba | R2H 2A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37234410 | Background | Mendelson AA, Erickson D, Villar R. The role of the microcirculation and integrative cardiovascular physiology in the pathogenesis of ICU-acquired weakness. Front Physiol. 2023 May 10;14:1170429. doi: 10.3389/fphys.2023.1170429. eCollection 2023. | |
| 26306719 | Background | 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. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012769 | Shock |
| D016638 | Critical Illness |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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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. |
| Tests will be conducted on up to two (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. | 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. | 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. | 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. | 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. | Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months. |
| Health Sciences Centre Winnipeg | Recruiting | Winnipeg | Manitoba | R3A 1R9 | Canada |
|
| 35680740 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D001519 | Behavior |