Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness

Sepsis Clinical Trial

Official title:

Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193980
• Other study ID #: HS25592
• Status: Recruiting
• Start date: December 15, 2023
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: University of Manitoba
• Contact: Asher Mendelson, MD PhD
• Phone: 204-787-1634
• Email: Asher.Mendelson[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Asthenia
• ICU Acquired Weakness
• Microvascular Dysfunction
• Sepsis
• Shock

Locations

Country	Name	City	State
Canada	Health Sciences Centre Winnipeg	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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

Outcome

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.