SepsisICUAWNCT07362862
MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
A study testing Electrical Muscle Stimulation System in people with Sepsis and Critical Illness, run by Health Discovery Labs at 3 sites in United States.
Trial summary
The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis, Critical Illness, ICU-acquired Muscle Weakness
- What is being tested?
- Electrical Muscle Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 May 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to ER or ICU within the previous 48 hours
- APACHE II score ≥ 13
- Meets the criteria for sepsis or severe sepsis
Who cannot join
- Anticipated transfer to an ICU not participating in this study
- Myopathies (e.g. congenital)
- Acquired myopathies with CK levels 5-times above the upper limit of normal
- Unable to transfer from bed to chair at baseline
- Moribund
- Comfort care
Show all 12Show fewer
- New onset deep vein thrombosis within the previous 6-months
- Malignancy in lower limb
- Technical obstacles - fracture, burns, amputation
- Open wound or skin abrasion at the garment application site
- Pregnancy
- Pacemaker and implantable cardioverter-defibrillator
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Grace RH McDonough, MD Candidate, Class of 2030 contact
United States3 sites, 3 recruiting
- Recruiting
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701
Paul H. Harford, M.D., 512-963-6362, PaulHarford@utexas.edu
Paul H. Harford, M.D.
- Recruiting
Ascension Seton Medical Center Austin
Austin, Texas, 78705
Paul H. Harford, M.D., 512-963-6362, PaulHarford@utexas.edu
Paul H. Harford, M.D.
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Division of Nursing Research, 507-422-5523, RSTnursingresearch@mayo.edu
Linda L. Chlan, Ph.D., RN, ATSF, FAAN, 507-255-5728, Chlan.Linda@mayo.edu
About this study
Official title: Safety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness
The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.
The main questions this study aims to answer are:
Read more
- Do participants develop medical problems when receiving electrical muscle stimulation in the ICU?
- Is electrical muscle stimulation a practical way to help reduce muscle weakness in critically ill patients?
Researchers will compare the control group (standard of care) to the intervention group (standard of care plus 60-minute sessions of electrical muscle stimulation daily during the ICU stay) to see if the device is safe and easy to use.
Participants will:
- Receive either standard of care or standard of care plus electrical muscle stimulation of the thigh muscles
- Have their muscle strength checked during the study
- Complete a survey three months after ICU discharge to check on their recovery
- Conditions
- Sepsis, Critical Illness, ICU-acquired Muscle Weakness, ICU-acquired Weakness, ICUAW, Sarcopenia
- Being tested
- Electrical Muscle Stimulation System
- Keywords
- Electrical muscle stimulation, Electrical Impedance Myography, Bioimpedance, Rehabilitation, Sepsis, Critical illness, ICU-acquired weakness
- Medical subject headings
- Sepsis, Critical Illness, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Muscle Stimulation SystemDevice
Participants will receive electrical muscle stimulation at the level of the quadriceps using the MyokinE100 device, a closed-loop electrical muscle stimulation system.
The closed-loop system monitors muscle response to electrical stimulation in real time using a biofeedback sensor and automatically adjusts stimulation intensity to achieve safe and effective muscle contractions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Participants will receive a daily 60-minute session of electrical muscle stimulation applied to the quadriceps for up to 7 days during ICU stay or until ICU discharge, alongside standard of care. Receives: Device: Electrical Muscle Stimulation System |
| Control Group | No intervention | Participants will receive standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
Lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Six muscle groups in lower limbs will be tested for a total best possible score of 30.
A 1-point increase in MRC score per muscle group in the lower limbs is considered clinically significant.
Measured: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Number of participants with unanticipated adverse device effects (UADE) related to MyokinE100 use from enrollment to hospital discharge.
A single Unanticipated Adverse Device Effect (UADE) in any participant during the study is considered significant.
Measured: From Day 1 (enrollment) through the end of the subject's study participation at 3-months.
Secondary outcomes (18)
Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
Upper and lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score scale grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Twelve muscle groups will be tested for a total possible best score of 60.
A 1-point change in MRC sum score is considered clinically significant.
Measured: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Change in hand-grip muscle strength measured by handheld dynamometry from ICU admission to hospital discharge.
Handgrip muscle strength will be assessed using a handheld dynamometer (HHD) as an indicator of global muscle function. Participants will be considered to have ICU-Acquired Weakness (ICUAW) if the average handgrip strength is below the threshold of 11Kg for men or 7 Kg for woman.
Higher scores in Kg indicate greater global muscle function.
Measured: Day 1 (day of enrollment) and daily in the ICU up to Day 14, and on hospital discharge day.
Change in mobility status assessed by ICU Mobility Scale (IMS) from ICU admission to ICU discharge.
Functional mobility will be assessed using the ICU Mobility Scale (IMS), which ranges from 0 (lying in bed, no active movement) to 10 (walking independently without a gait aid).
Higher scores indicate greater mobility.
Measured: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Change in functional exercise capacity assessed by Six-Minute Walk Test (6MWT) between ICU discharge to hospital discharge.
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) which measures the distance a participant can walk on a flat surface in six minutes.
A greater distance walked indicates better functional status.
Measured: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.
Change in functional exercise capacity assessed by 30-Second Sit-to-Stand Test (30 s STS) between ICU discharge to hospital discharge.
Functional exercise capacity will be assessed using the 30-Second Sit-to-Stand Test (30 s STS) which measures how many times a person can stand up from and sit down (one repetition) in an armless chair in 30 seconds.
A higher number of repetitions indicates greater functional capacity.
Measured: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.
Change in Rectus Femoris muscle structure assessed by musculoskeletal ultrasound from ICU admission to hospital discharge.
The Rectus Femoris muscle structure will be evaluated using musculoskeletal ultrasound. Measurements will include cross-sectional area, muscle circumference, pennation angle, and echo-intensity.
Higher cross-sectional area, muscle circumference, and pennation angle indicate better muscle structure, while increased echo-intensity suggests worse muscle structure.
Measured: From ICU admission to day 14.
Change in frailty status assessed by Clinical Frailty Scale (CFS) from ICU admission to 3-month post hospital discharge.
Frailty will be assessed using the Clinical Frailty Scale (CFS), which ranges from 1 (very fit) to 7 (severely frail).
Higher scores are worse.
Measured: Enrollment to 3-month follow-up.
Change in functional independence assessed by Barthel Index from ICU discharge to hospital discharge.
Functional independence will be assessed using the Barthel Index, which measures patient's ability in 10 activities of daily living (feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, chair transfers, mobility on level surfaces, and stairs).
A higher score closer to 100 indicate greater functional independence.
Measured: Enrollment to 3-month follow-up.
Change in fatigue severity assessed by Visual Analog Scale for Fatigue (VAS-F) from ICU admission to hospital discharge.
Fatigue will be assessed using the Visual Analog Scale for Fatigue (VAS-F), where participants rate their fatigue on a scale from 0 (no fatigue) to 10 (worst possible fatigue).
Higher scores indicate greater fatigue.
Measured: From ICU admission up to Day 14 or upon ICU discharge whichever comes first.
Change in health-related quality of life assessed by the RAND 36-Item Health Survey (SF-36) from the time of hospital discharge to 3-month follow-up after hospital discharge.
Health-related quality of life will be assessed using the RAND 36-Item Health Survey (SF-36), which evaluates eight domains including physical functioning, role limitations, pain, general health, vitality, social functioning, emotional well-being, and mental health. Scores range from 0 to 100, with higher scores indicating better health status.
Measured: Hospital discharge to 3-month follow-up after hospital discharge.
Change in employment status and work ability after hospital discharge.
Employment status will be assessed during follow-up after hospital discharge using a structured questionnaire. Participants will report their current employment status and whether their ICU stay affected their ability to work.
Return to work is considered best outcome.
Measured: From ICU discharge to 3-month follow up after hospital discharge.
Duration of mechanical ventilation.
The number of days from the initiation of mechanical ventilation to the discontinuation of mechanical ventilation.
A lower number of days is better.
Measured: From ICU admission to ICU discharge, an average of 7 days.
Number of ventilator-free days within 28 days after ICU admission.
Ventilator-free days will be calculated as 28 minus total number of days on invasive mechanical ventilation during which the participant is alive and not receiving invasive mechanical ventilation.
Participants who die within 28 days will be assigned zero ventilator-free days.
Measured: From extubation to day 28.
Number of days in ICU, hospital ward, and total hospital stay from admission to discharge.
Length of stay will be recorded in three categories: (1) ICU stay, defined as the total number of consecutive days from ICU admission to ICU discharge; (2) ward stay, defined as the number of days spent in a hospital ward after ICU discharge; and (3) total hospital stay, defined as the number of days from hospital admission to hospital discharge.
The shorter the length of stay, the better.
Measured: From hospital admission to hospital discharge, an average of 14 days.
Discharge location after hospital stay.
Discharge location will be recorded at the time of hospital discharge using predefined categories: home, home with home health services, inpatient rehabilitation facility, skilled nursing facility, long-term acute care hospital, hospice, or death.
Discharge home is considered the best outcome.
Measured: At the last day of hospitalization, average day 14.
Number of participants tolerating electrical muscle stimulation sessions during ICU stay.
Treatment session tolerance will be assessed using standardized scales.
Tolerance is defined as:
- CPOT less than 7
- NRS less than 8 at the thigh level
- RASS less than +3
Scale ranges:
- CPOT (0 = relaxed, 8 = severe pain/agitation)
- NRS for pain (0 = no pain, 10 = worst pain),
- RASS (-5 = unarousable, +4 = combative)
Measured: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Number of participants with electrical interference on ECG monitoring during the stimulation sessions in the ICU.
Electrical interference with cardiac monitoring will be assessed during each electrical muscle stimulation (EMS) session using ECG tracings from standard ICU cardiac monitoring devices. Interference is defined as continuous 60-cycle (60 Hz) artifact for more than 60 seconds that impairs accurate interpretation of cardiac rhythm. ECG data will be captured only during EMS intervention sessions.
Success is defined as 20% or less of ECG samples showing electrical interference as defined above.
Measured: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Number of participants achieving significant muscle contraction during electrical muscle stimulation sessions as assessed by Muscle Contraction Scale during the ICU stay.
"Muscle contraction during electrical muscle stimulation (EMS) sessions will be assessed using the Muscle Contraction Scale, which classifies contraction from Type 1 (no palpable or visible contraction) to Type 5 (palpable and visible contraction with full muscle bulk).
Participants achieved a response if they scored muscle contraction grade 3 or higher.
Measured: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start5 May 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of participants will each receive different interventions
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Discovery Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Mayo Clinic, Ascension Health, University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Oussama Hassan, M.D., Principal investigator, Health Discovery Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362862
- Sponsor's protocol ID
- STUDY00006725
- Other IDs
- R44EB033725
- Acronym
- ICUAW
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness
- ClinicalTrials.gov ID
- NCT07362862
- Acronym / sponsor ID
- ICUAW / STUDY00006725
- Conditions
- Sepsis, Critical Illness, ICU-acquired Muscle Weakness, ICU-acquired Weakness, ICUAW, Sarcopenia
- Keywords
- Electrical muscle stimulation, Electrical Impedance Myography, Bioimpedance, Rehabilitation, Sepsis, Critical illness, ICU-acquired weakness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Health Discovery LabsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Mayo Clinic, Ascension Health, University of Texas at Austin
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.
The main questions this study aims to answer are:
- Do participants develop medical problems when receiving electrical muscle stimulation in the ICU?
- Is electrical muscle stimulation a practical way to help reduce muscle weakness in critically ill patients?
Researchers will compare the control group (standard of care) to the intervention group (standard of care plus 60-minute sessions of electrical muscle stimulation daily during the ICU stay) to see if the device is safe and easy to use.
Participants will:
- Receive either standard of care or standard of care plus electrical muscle stimulation of the thigh muscles
- Have their muscle strength checked during the study
- Complete a survey three months after ICU discharge to check on their recovery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of participants will each receive different interventions
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Electrical Muscle Stimulation SystemParticipants will receive a daily 60-minute session of electrical muscle stimulation applied to the quadriceps for up to 7 days during ICU stay or until ICU discharge, alongside standard of care. |
| Control Group | No intervention | –Participants will receive standard of care only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to ER or ICU within the previous 48 hours
- APACHE II score ≥ 13
- Meets the criteria for sepsis or severe sepsis
Key exclusion criteria (12 listed)
- Anticipated transfer to an ICU not participating in this study
- Myopathies (e.g. congenital)
- Acquired myopathies with CK levels 5-times above the upper limit of normal
- Unable to transfer from bed to chair at baseline
- Moribund
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Muscle Stimulation SystemParticipants will receive electrical muscle stimulation at the level of the quadriceps using the MyokinE100 device, a closed-loop electrical muscle stimulation system. The closed-loop system monitors muscle response to electrical stimulation in real time using a biofeedback sensor and automatically adjusts stimulation intensity to achieve safe and effective muscle contractions. | Device | Intervention Group |
Primary outcome
Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Six muscle groups in lower limbs will be tested for a total best possible score of 30. A 1-point increase in MRC score per muscle group in the lower limbs is considered clinically significant.
Number of participants with unanticipated adverse device effects (UADE) related to MyokinE100 use from enrollment to hospital discharge.
Time frame: From Day 1 (enrollment) through the end of the subject's study participation at 3-months.
A single Unanticipated Adverse Device Effect (UADE) in any participant during the study is considered significant.
18 secondary outcomes
Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Change in hand-grip muscle strength measured by handheld dynamometry from ICU admission to hospital discharge.
Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14, and on hospital discharge day.
Change in mobility status assessed by ICU Mobility Scale (IMS) from ICU admission to ICU discharge.
Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Change in functional exercise capacity assessed by Six-Minute Walk Test (6MWT) between ICU discharge to hospital discharge.
Time frame: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.
Change in functional exercise capacity assessed by 30-Second Sit-to-Stand Test (30 s STS) between ICU discharge to hospital discharge.
Time frame: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.
Change in Rectus Femoris muscle structure assessed by musculoskeletal ultrasound from ICU admission to hospital discharge.
Time frame: From ICU admission to day 14.
Change in frailty status assessed by Clinical Frailty Scale (CFS) from ICU admission to 3-month post hospital discharge.
Time frame: Enrollment to 3-month follow-up.
Change in functional independence assessed by Barthel Index from ICU discharge to hospital discharge.
Time frame: Enrollment to 3-month follow-up.
Change in fatigue severity assessed by Visual Analog Scale for Fatigue (VAS-F) from ICU admission to hospital discharge.
Time frame: From ICU admission up to Day 14 or upon ICU discharge whichever comes first.
Change in health-related quality of life assessed by the RAND 36-Item Health Survey (SF-36) from the time of hospital discharge to 3-month follow-up after hospital discharge.
Time frame: Hospital discharge to 3-month follow-up after hospital discharge.
Change in employment status and work ability after hospital discharge.
Time frame: From ICU discharge to 3-month follow up after hospital discharge.
Duration of mechanical ventilation.
Time frame: From ICU admission to ICU discharge, an average of 7 days.
Number of ventilator-free days within 28 days after ICU admission.
Time frame: From extubation to day 28.
Number of days in ICU, hospital ward, and total hospital stay from admission to discharge.
Time frame: From hospital admission to hospital discharge, an average of 14 days.
Discharge location after hospital stay.
Time frame: At the last day of hospitalization, average day 14.
Number of participants tolerating electrical muscle stimulation sessions during ICU stay.
Time frame: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Number of participants with electrical interference on ECG monitoring during the stimulation sessions in the ICU.
Time frame: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Number of participants achieving significant muscle contraction during electrical muscle stimulation sessions as assessed by Muscle Contraction Scale during the ICU stay.
Time frame: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace RH McDonough, MD Candidate, Class of 2030 contact
Oussama Hassan, M.D. principal investigator
Health Discovery Labs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Muscle Stimulation System in people with Sepsis and Critical Illness, run by Health Discovery Labs at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oussama Hassan, M.D. (512-203-9474, O.Hassan@healthdiscoverylabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge. (time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.