Intensive Care Unit Acquired Weakness (ICUAW)eStimCycleNCT02214823
eStimCycle: Early Rehabilitation in Critical Care
A study testing FES-Cycling in people with Intensive Care Unit Acquired Weakness (ICUAW), run by Associate Professor Sue Berney PhD, BPT at 4 sites in 2 countries.
Trial summary
Project Summary: Patients who have a length of stay four or more days in ICU and requiring mechanical ventilation assistance to breathe for more than 48 hours will be invited to participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness (ICUAW)
- What is being tested?
- FES-Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2012to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years,
- expected mechanical ventilation or ECMO >48 h with evidence of systemic inflammation as defined by American College of Chest Physicians (ACCP) Consensus Conference Criteria and
- predicted ICU length of stay ≥4 days.
Who cannot join
- Known primary systemic neuromuscular disease or intracranial process on ICU admission
- Lower limb amputation/s
- Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
- Assessed by medical staff as not-expected to survive ICU
- Pregnancy
- BMI > 40
Show all 18Show fewer
- Presence of external fixator or superficial metal in lower limb
- Open wounds or skin abrasions at electrode application points
- Presence of cardiac or diaphragmatic pacemaker or implanted defibrillator with no underlying rhythm, as confirmed by the treating physician
- Transferred from another ICU after > 2 days of mechanical ventilation
- Platelets < 40 000 and INR > 1.6 (for muscle biopsy)
- Lower limb malignancy
- Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions.
- Non-English speaking background restricting the individuals ability to accurately and consistently follow instructions.
- Exclusion criteria for the 6 and 12 month cognitive testing follow-up portion of the study:
- Cognitive impairment (IQCODE >3.3) done by proxy after informed consent obtained
- No fixed home address
- Score >= 10 on Alcohol use disorders and identification test (AUDIT)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Duke University
Durham, North Carolina, 27708
Australia2 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006
Austin Hospital
Melbourne, Victoria, 3084
About this study
Official title: Functional Electrical Stimulation Assisted Cycling (eStimCycle):A Novel Intervention to Improve Outcomes in the Critically Ill
Project Summary: Patients who have a length of stay four or more days in ICU and requiring mechanical ventilation assistance to breathe for more than 48 hours will be invited to participate. Participants will be randomised to either receive Functional Electrical Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously been shown to improve physical function, patients who receive cycling as a treatment will have one leg that cycles and the other leg that cycles with assistance of electrical stimulation as we want to establish the effectiveness of the addition of electrical stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive function will also be measured at hospital discharge, 6- and 12-month follow-up. A small group of patients in this study will be invited to provide samples of blood, urine and muscle at ICU admission and discharge to try and determine what happens to muscle in patients who are critically ill.
Significance of the Project: This is an important study because the development of ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function. Early treatment to maintain strong muscles during an intensive care stay may help speed up recovery and enhance participation in other rehabilitation treatments and improve functional activities and cognition. These are important objectives for both patients and their families. In addition understanding why the muscles become so weak so quickly in patients in ICU will help to develop treatments that may help to maintain muscle strength.
Read more
Study Hypotheses:
Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at hospital discharge.
Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at 6 month follow up.
Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care rehabilitation.
- Being tested
- FES-Cycling, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES-CyclingDevice
Also called Cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.), six channel SAGE stimulator and two RT50 wireless stimulator channels.
Standard CareOther
standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.
| Study group | Role | What they receive |
|---|---|---|
| FES-Cycling | Experimental | Timeframe: Within 72 hours of ICU admission. Program: Standard care physiotherapy AND up to one hour of supine cycling daily using a cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.) attached to a six channel stimulator (SAGE) and 2 additional RT50 wireless stimulator channels.
One leg will undergo cycling alone without the electrodes turned on (sham) and the other leg will undergo cycling and muscle stimulation. Electrodes will be placed on all major lower limb muscles. Intervention will be provided individually and supervised by a physiotherapist in ICU only. Duration /Intensity: Up to 1 hour at least 5 times a week for 28 days or ICU discharge, if 20 sessions have not occurred at this time, intervention will continue until this is achieved. Intensity of muscle stimulation will be delivered at a level able to cause visible muscle contractions, confirmed by palpation.
A subgroup of 10 individuals will be involved in biomarker analyses. Receives: Device: FES-Cycling; Other: Standard Care |
| Standard Care | Active comparator | Both groups will receive usual medical and nursing care in the ICU and ward. Both groups (control and intervention) will receive standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.
A subgroup of 10 individuals will be involved in biomarker analyses. This will involve collection of muscle biopsy, blood and urine analyses at baseline and ICU discharge. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass and cross sectional area
Bioimpedance Spectroscopy will be used to evaluate changes in muscle mass. Ultrasonography of the quadriceps will assess changes in muscle thickness and cross sectional area
Measured: Baseline, weekly in ICU for an average 2 weeks and at CU discharge (on average 14 days) with participants beng followed for the duration of hospital stay, an expected average of 4 weeks
Muscle Strength
This will be assessed using the Medical Research Council Scale for identifying muscle weakness in ICU and also hand-held dynamometry for grip strength and isometric quadriceps strength
Measured: Baseline, weekly in ICU for an average 2 weeks and at ICU discharge (on average 14 dats) with participants beng followed for the duration of hospital stay on average of 4 weeks. Hand-held dynamometry will also be assessed at 6 and 12 months.
Neuropsychological Battery of Tests
Including the following tests: Hayling Sentence Completion, Weschler Adult Intelligence Scale (Digit Span and Similarities), Weschler Memory III (Logical Memory 1 and 2) and Cognistat (Judgment and Orientation), and Controlled Oral Word Association
Measured: 6 and 12 months post ICU discharge
Secondary outcomes (9)
Biomarker analyses
Muscle biopsy, 24 hour urine collection and blood analyses in subgroup of n=20 from main pilot randomised controlled trial.
Measured: Baseline and ICU discharge with an expected average stay of 14 days
Hours of mechanical ventilation, ICU hours and ICU readmission
This will be collected from medical records data. This will all be reported at the completion of the trial
Measured: trial completion
Confusion Assessment Method for ICU (CAM-ICU)
The CAM-ICU is a tool for screening for delirium in critically ill patients.
Measured: Daily in ICU for an expected average of 14 days
Montreal Cognitive Assessment (MoCA)
A screening tool for cognitive impairment
Measured: Hospital discharge and expected stay on average of 4 weeks
Activities of Daily Living and Instrumental Activities of Daily Living
Two short and simple questionnaires assessing activities of daily living.
Measured: Baseline, 90-day status, 6-month call
Physical function
The physical function in ICU test (PFIT), functional status score in the ICU (FSS-ICU), short physical performance battery (SPPB) and six minute walk test (6MWT).
Measured: Baseline and then weekly until ICU discharge an expected stay on average of 14 days. SPPB and 6MWT will also be measured at hospital discharge with an average length of stay of 4 weeks. 6MWT will be assessed and 6 and 12 months.
Informant Questionnaire on Cognitive Decline in the Elderly, short form (IQCODE-SF)
The IQCODE-SF for cognitive dysfunction will be completed at baseline by the proxy after obtaining informed consent.
Measured: Baseline
Hospital Anxiety and Depression Scale
A scale used to detect the states of anxiety and depression
Measured: 6 and 12 months post recruitment
Impact of Events Scale - Revised (IES-R)
IES-R is an instrument to measure the subjective response to a specific traumatic event, especially in the response sets of intrusion (intrusive thoughts, nightmares, intrusive feelings and imagery, dissociative-like re-experiencing), avoidance (numbing of responsiveness, avoidance of feelings, situations, and ideas), and hyperarousal (anger, irritability, hypervigilance, difficulty concentrating, heightened startle), as well as a total subjective stress IES-R score.
Measured: 6 and 12 months post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJul 2012
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit Acquired Weakness (ICUAW)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associate Professor Sue Berney PhD, BPT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Associate Professor Sue Berney PhD, BPT, University of Melbourne
- Investigators
- Linda Denehy, PhD, Principal investigator, University of MelbourneSusan Berney, PhD, Principal investigator, Austin HealthDale Needham, PhD, Principal investigator, Johns Hopkins UniversityJennifer Paratz, PhD, Principal investigator, Royal Brisbane and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214823
- Sponsor's protocol ID
- ACTRN12612000528853
- Acronym
- eStimCycle
- Status last verified
- Oct 2018
- First submitted
- 7 Aug 2014
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parry SM, Berney S, Koopman R, Bryant A, El-Ansary D, Puthucheary Z, Hart N, Warrillow S, Denehy L. Early rehabilitation in critical care (eRiCC): functional electrical stimulation with cycling protocol for a randomised controlled trial. BMJ Open. 2012 Sep 13;2(5):e001891. doi: 10.1136/bmjopen-2012-001891. Print 2012.
PubMed 22983782Parry SM, Berney S, Granger CL, Koopman R, El-Ansary D, Denehy L. Electrical muscle stimulation in the intensive care setting: a systematic review. Crit Care Med. 2013 Oct;41(10):2406-18. doi: 10.1097/CCM.0b013e3182923642.
PubMed 23921276Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.
PubMed 24768534Berney S, Hopkins RO, Rose JW, Koopman R, Puthucheary Z, Pastva A, Gordon I, Colantuoni E, Parry SM, Needham DM, Denehy L. Functional electrical stimulation in-bed cycle ergometry in mechanically ventilated patients: a multicentre randomised controlled trial. Thorax. 2021 Jul;76(7):656-663. doi: 10.1136/thoraxjnl-2020-215093. Epub 2020 Dec 15.
PubMed 33323480Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional outcomes in ICU - what should we be using? - an observational study. Crit Care. 2015 Mar 29;19(1):127. doi: 10.1186/s13054-015-0829-5.
PubMed 25888469
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation Assisted Cycling (eStimCycle):A Novel Intervention to Improve Outcomes in the Critically Ill
- ClinicalTrials.gov ID
- NCT02214823
- Acronym / sponsor ID
- eStimCycle / ACTRN12612000528853
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Associate Professor Sue Berney PhD, BPTUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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.
Project Summary: Patients who have a length of stay four or more days in ICU and requiring mechanical ventilation assistance to breathe for more than 48 hours will be invited to participate. Participants will be randomised to either receive Functional Electrical Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously been shown to improve physical function, patients who receive cycling as a treatment will have one leg that cycles and the other leg that cycles with assistance of electrical stimulation as we want to establish the effectiveness of the addition of electrical stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive function will also be measured at hospital discharge, 6- and 12-month follow-up. A small group of patients in this study will be invited to provide samples of blood, urine and muscle at ICU admission and discharge to try and determine what happens to muscle in patients who are critically ill.
Significance of the Project: This is an important study because the development of ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function. Early treatment to maintain strong muscles during an intensive care stay may help speed up recovery and enhance participation in other rehabilitation treatments and improve functional activities and cognition. These are important objectives for both patients and their families. In addition understanding why the muscles become so weak so quickly in patients in ICU will help to develop treatments that may help to maintain muscle strength.
Study Hypotheses:
Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at hospital discharge.
Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at 6 month follow up.
Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES-Cycling | Experimental | Device: FES-Cycling, Other: Standard CareTimeframe: Within 72 hours of ICU admission. Program: Standard care physiotherapy AND up to one hour of supine cycling daily using a cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.) attached to a six channel stimulator (SAGE) and 2 additional RT50 wireless stimulator channels. One leg will undergo cycling alone without the electrodes turned on (sham) and the other leg will undergo cycling and muscle stimulation. Electrodes will be placed on all major lower limb muscles. Intervention will be provided individually and supervised by a physiotherapist in ICU only. Duration /Intensity: Up to 1 hour at least 5 times a week for 28 days or ICU discharge, if 20 sessions have not occurred at this time, intervention will continue until this is achieved. Intensity of muscle stimulation will be delivered at a level able to cause visible muscle contractions, confirmed by palpation. A subgroup of 10 individuals will be involved in biomarker analyses. |
| Standard Care | Active comparator | Other: Standard CareBoth groups will receive usual medical and nursing care in the ICU and ward. Both groups (control and intervention) will receive standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training. A subgroup of 10 individuals will be involved in biomarker analyses. This will involve collection of muscle biopsy, blood and urine analyses at baseline and ICU discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years,
- expected mechanical ventilation or ECMO >48 h with evidence of systemic inflammation as defined by American College of Chest Physicians (ACCP) Consensus Conference Criteria and
- predicted ICU length of stay ≥4 days.
Key exclusion criteria (18 listed)
- Known primary systemic neuromuscular disease or intracranial process on ICU admission
- Lower limb amputation/s
- Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
- Assessed by medical staff as not-expected to survive ICU
- Pregnancy
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 |
|---|---|---|
| FES-CyclingAlso: Cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.), six channel SAGE stimulator and two RT50 wireless stimulator channels. | Device | FES-Cycling |
| Standard Carestandard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training. | Other | FES-Cycling, Standard Care |
Primary outcome
Muscle mass and cross sectional area
Time frame: Baseline, weekly in ICU for an average 2 weeks and at CU discharge (on average 14 days) with participants beng followed for the duration of hospital stay, an expected average of 4 weeks
Bioimpedance Spectroscopy will be used to evaluate changes in muscle mass. Ultrasonography of the quadriceps will assess changes in muscle thickness and cross sectional area
Muscle Strength
Time frame: Baseline, weekly in ICU for an average 2 weeks and at ICU discharge (on average 14 dats) with participants beng followed for the duration of hospital stay on average of 4 weeks. Hand-held dynamometry will also be assessed at 6 and 12 months.
This will be assessed using the Medical Research Council Scale for identifying muscle weakness in ICU and also hand-held dynamometry for grip strength and isometric quadriceps strength
Neuropsychological Battery of Tests
Time frame: 6 and 12 months post ICU discharge
Including the following tests: Hayling Sentence Completion, Weschler Adult Intelligence Scale (Digit Span and Similarities), Weschler Memory III (Logical Memory 1 and 2) and Cognistat (Judgment and Orientation), and Controlled Oral Word Association
9 secondary outcomes
Biomarker analyses
Time frame: Baseline and ICU discharge with an expected average stay of 14 days
Hours of mechanical ventilation, ICU hours and ICU readmission
Time frame: trial completion
Confusion Assessment Method for ICU (CAM-ICU)
Time frame: Daily in ICU for an expected average of 14 days
Montreal Cognitive Assessment (MoCA)
Time frame: Hospital discharge and expected stay on average of 4 weeks
Activities of Daily Living and Instrumental Activities of Daily Living
Time frame: Baseline, 90-day status, 6-month call
Physical function
Time frame: Baseline and then weekly until ICU discharge an expected stay on average of 14 days. SPPB and 6MWT will also be measured at hospital discharge with an average length of stay of 4 weeks. 6MWT will be assessed and 6 and 12 months.
Informant Questionnaire on Cognitive Decline in the Elderly, short form (IQCODE-SF)
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: 6 and 12 months post recruitment
Impact of Events Scale - Revised (IES-R)
Time frame: 6 and 12 months post recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 22983782Parry SM, Berney S, Koopman R, Bryant A, El-Ansary D, Puthucheary Z, Hart N, Warrillow S, Denehy L. Early rehabilitation in critical care (eRiCC): functional electrical stimulation with cycling protocol for a randomised controlled trial. BMJ Open. 2012 Sep 13;2(5):e001891. doi: 10.1136/bmjopen-2012-001891. Print 2012.
- Background: PubMed 23921276Parry SM, Berney S, Granger CL, Koopman R, El-Ansary D, Denehy L. Electrical muscle stimulation in the intensive care setting: a systematic review. Crit Care Med. 2013 Oct;41(10):2406-18. doi: 10.1097/CCM.0b013e3182923642.
- Background: PubMed 24768534Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.
- Derived from this study: PubMed 33323480Berney S, Hopkins RO, Rose JW, Koopman R, Puthucheary Z, Pastva A, Gordon I, Colantuoni E, Parry SM, Needham DM, Denehy L. Functional electrical stimulation in-bed cycle ergometry in mechanically ventilated patients: a multicentre randomised controlled trial. Thorax. 2021 Jul;76(7):656-663. doi: 10.1136/thoraxjnl-2020-215093. Epub 2020 Dec 15.
- Derived from this study: PubMed 25888469Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional outcomes in ICU - what should we be using? - an observational study. Crit Care. 2015 Mar 29;19(1):127. doi: 10.1186/s13054-015-0829-5.
Related trials for Intensive Care Unit Acquired Weakness (ICUAW)
Recruiting
MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
Sepsis, Critical Illness
Recruiting
Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge
ICU Acquired Weakness (ICUAW)
RecruitingObservational study
Dosage of Early Rehabilitation of ICU Patients
Critical Care, Intensive Care, Critical Illness
RecruitingObservational study
Recovery From ICUAW Following Severe Respiratory and Cardiac Failure
Intensive Care Unit Syndrome, Intensive Care Neuropathy
Enrolling by invitationObservational study
Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness
Cohort Studies, ICU Acquired Weakness (ICUAW)
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. This study is not recruiting at the moment.
Linda Denehy, PhD principal investigator
University of Melbourne
Susan Berney, PhD principal investigator
Austin Health
Dale Needham, PhD principal investigator
Johns Hopkins University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES-Cycling in people with Intensive Care Unit Acquired Weakness (ICUAW), run by Associate Professor Sue Berney PhD, BPT at 4 sites in 2 countries.
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 18 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: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass and cross sectional area (time frame: Baseline, weekly in ICU for an average 2 weeks and at CU discharge (on average 14 days) with participants beng followed for the duration of hospital stay, an expected average of 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214823, which also lists 5 linked publications.
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 11 Oct 2018.