Sepsis Clinical Trial
Official title:
Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness
NCT number | NCT06193980 |
Other study ID # | HS25592 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 15, 2023 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Health Sciences Centre Winnipeg | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
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. — View 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. Erratum In: Intensive Care Med Exp. 2023 Jan 5;11(1):1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microvascular Hemoglobin Content | Microvascular regulation of blood flow distribution will be analyzed with near-infrared spectroscopy (NIRS) device by showing time-dependent changes Total hemoglobin (THb) on the brachioradialis muscle to characterize microvascular function. This will be recorded at rest for 20 minutes. | 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. | |
Primary | Vascular Occlusion Test | Blood pressure cuff will be inflated to 180 mmHg or 30 mmHg above systolic blood pressure (whichever is higher) and kept occluded for 3 minutes, followed by release and continued monitoring for 5 minutes. NIRS is simultaneously applied to the brachioradialis and change in tissue saturation index is measured throughout the test. | 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. | |
Primary | 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 three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 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 three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 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 three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 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 three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 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 three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 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. | Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 6-minute walk distance | distance (meters) walked in 6 minutes will be evaluated as a general marker of fitness, in accordance with standard American Thoracic Society (ATS) guidelines | Tests will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 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 three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Primary | 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 three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Secondary | 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 four (4) different occasions after ICU discharge: (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 12 months. | |
Secondary | 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. | Questionnaire will be conducted on up to three (3) different occasions after ICU discharge: (i) 3 months, (ii) 6 months, and (iii) 12 months. | |
Secondary | Postural Transitions | Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) will be recorded continuously during postural transitions (lie to stand; sit to stand) to evaluate cardiovascular blood flow regulation | 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 | Recruitment and retention | The number of completed sessions within 12 months for each eligible patient will be recorded. | Ongoing throughout 12 months after ICU discharge | |
Secondary | NIRS deoxygenation during handgrip (deoxy-hemoglobin) | NIRS will be applied to the brachioradialis during handgrip. Deoxygenation profile, as measured by increase in deoxy-hemoglobin, will be recorded throughout incremental increases in handgrip intensity. | 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. | |
Secondary | NIRS deoxygenation during handgrip (tissue saturation index) | NIRS will be applied to the brachioradialis during handgrip. Deoxygenation profile, as measured by decrease in tissue saturation index, will be recorded throughout incremental increases in handgrip intensity. | 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. |
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