Intensive Care Unit SyndromeCLEVERERNCT03753412
Recovery From ICUAW Following Severe Respiratory and Cardiac Failure
An observational study of Intensive Care Unit Syndrome and Intensive Care Neuropathy, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
To observe and identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) following a severe cardiorespiratory failure requiring extra-corporeal membrane oxygenation (ECMO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome, Intensive Care Neuropathy, Intensive Care (ICU) Myopathy
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Apr 2019to 26 Sep 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with severe cardiac or respiratory failure requiring extra-corporeal membrane oxygenation with no pre-existing muscle weakness or wasting.
Who may be able to join
- Above the age of 18
- Adults with severe cardio-respiratory failure requiring ECMO.
- Adults who have had personal and professional consultees agree to enrol them in the trial.
Who cannot join
- Previous Stroke
- Neuromuscular disease
- Malignancy
- Underlying neuromuscular disease
- paediatrics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's hospital (Barts NHS trust)
London, EC1A 7BE
Griffiths, Mark Griffiths, FRRCP, PhD, 447875999126, Mark.Griffiths@bartshealth.nhs.uk
Griffiths, Mark Griffiths, FRCP, PhD
About this study
Official title: Prospective Observational Study Regarding the Determinants of Functional Disability and Quality of Life in Patients Recovering From Severe Acute Cardiac or Respiratory Failure Considered for Mechanical Cardiorespiratory Support (CLEVERER)
To observe and identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) following a severe cardiorespiratory failure requiring extra-corporeal membrane oxygenation (ECMO). Additionally, to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. CLEVERER is a clinical observational pilot study.
Read the detailed description
To identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. This phenomenon has become more evident over recent years and still requires extensive research.
ICUAW is an umbrella term for more specifically polyneuropathy and myopathy. Recent research has found that 50% of patients undergoing elective cardiac surgery lose significant muscle mass (9.6% in the wasters group) within the first seven days. These patients are receiving relatively uncomplicated surgery yet still suffering from muscle breakdown, which cannot be described by inactivity alone. The investigators wish to observe ICUAW in a real-life context, however, where cases are always severe. ICUAW can lead to a significant increase in mortality and morbidity. Risk factors for ICUAW include neuromuscular blocking agents, hyperglycaemia, inactivity and sepsis. The correlation between a patient group with severe cardiorespiratory failure and patient-centred outcomes during recovery such as functional ability and health-related quality of life (HRQoL) has been little studied.
Severe cardiac and respiratory failure can both be supported by a mechanical cardio-respiratory support (MCS) including extra-corporeal membrane oxygenation (ECMO); therefore referral for this intervention can be used as a marker of the severest form of cardiorespiratory failure. Both conditions are associated with a high incidence of collateral multi-organ dysfunction and mortality; as well as long-term morbidity, loss of independence and reduced quality of life. Patients with acute cardiac and respiratory failure referred to St Bartholomew's hospital for consideration of MCS will be recruited by advice/guidance from a personal and professional consultee.
Rectus femoris cross-sectional area (RFcsa) will be measured by ultrasound during the first week of admission and at pre-determined time points. The RFcsa will be correlated with indices of muscle strength, physical function and HRQoL. The investigators will also take blood and urine samples on arrival and at pre-defined intervals during the patients' admission for circulating and respiratory markers of sepsis, oxidative stress and organ injury. A muscle biopsy will be taken from the operation field if the patient is centrally cannulated when initiating ECMO.
The primary Objective is to identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after severe cardiorespiratory failure. Specifically, to observe the cross-sectional area of the Rectus Femoris (RFcsa) and correlate this with muscle strength and HRQoL during recovery. RFcsa, hand-held dynamometry, knee straightening dynamometry, Free Fat Mass Index, standing and lying vital capacity, MRC-SS sum score and short physical performance battery (SPPB) will be observed. Also, HRQoL will be measured using the reintegration to normal living index (RNLI), hospital and anxiety depression score (HADS)and the EQ-5D-5L (EuroQol research foundation). Additionally, we have composed a 10 item questionnaire to assess pre-morbid functional status. The primary endpoint will be once all these data are gathered and analysed.
The secondary aim is to understand the molecular and genomic profile of blood samples and the histology of the muscle biopsies. The objective will be supported with additional data from urine analysis (albumin-creatinine ratio) and vascular endothelial cells. The secondary endpoint will be once these data are collected and analysed.
- Conditions
- Intensive Care Unit Syndrome, Intensive Care Neuropathy, Intensive Care (ICU) Myopathy, Acute Respiratory Distress Syndrome, Cardiac Failure, Respiratory Failure
- Keywords
- Extra Corporeal Membrane Oxygenation (ECMO), Intensive Care Unit Acquired Weakness (ICUAW), Critical Illness Polyneuromyopathy (CIPM), Ultrasound (US), Health Related Quality of Life (HRQoL)
- Medical subject headings
- Muscular Diseases, Respiratory Distress Syndrome, Heart Failure, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICUAW ECMO group | The physical and psychological effects of ICUAW on patients receiving extracorporeal membrane oxygenation for severe cardiorespiratory failure will be observed. Physical function and HRQoL will be analysed and correlated with RFcsa. Additionally, biological markers will be used to understand molecular and genomic profiles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the change in cross sectional area of the Rectus Femoris (RFcsa, measured in cm2) during critical illness and recovery.
RFcsa will be calculated using B-mode ultrasound (US) at pre-determined time points. Additionally, the images acquired will have histogram analysis in adobe photoshop software. The RFcsa will be correlated with indices of muscle strength and HRQoL. A larger RFcsa with reduced pixel density suggests greater muscle quality and function.
Measured: Up to approximately 1 year.
To Observe a change in Hand Held Dynamometry strength and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Hand-held dynamometry will be calculated using the JAMAR hand-held hydraulic dynamometer. We will assess both hands and take the mean of 3 trials, producing a maximal grip result. A higher score indicates better global strength and function.
Measured: Up to approximately 1 year.
To observe a change in Knee straightening dynamometry, strength and joint moment (torque) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
The test will be conducted using a Lafayette Manual Muscle Tester. Joint knee moment (torque) and strength will be measured. A higher result from joint knee moment and strength indicates a greater global strength and function.
Measured: Up to approximately 1 year
To test the Medical Research Council Sum Score (MRC-SS). MRC-SS measures global strength and ambulation
This test will be conducted once to reaffirm whether patients' have ICUAW. A score can range from 0 (paralysis) to 60 (normal strength). A score of less than 48 indicates the patient has ICUAW. Therefore, a lower score is associated with worse outcomes.
Measured: Up to approximately 1 year.
To observe a change in Short Physical Performance Battery (SPPB) and correlate this with RFcsa, function and HRQoL during critical illness and recovery
SPPB will be used as a further marker of functional status. The patient can score between 0 (poor functional status) and 12 (good functional status).
Measured: Up to approximately 1 year.
Lying and Standing Vital Capacity (FVC - forced vital capacity) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Lying and standing vital capacity will be measured using a hand held spirometer. The test score will be compared to the predicted normal value based on age, height, race and gender. A result is considered normal if it is 80 percent or more of the predicted value.
Measured: Up to approximately 1 year
To measure a change in Free Fat Mass Index (FFMI) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Free fat mass index (FFMI) and free fat mass (FFM) will be measured using the bodystat 1500 device. Other values will also be recorded from the test including body fat percentage and lean mass percentage. The body stat 1500 is an electrical device that uses electrical impedance to obtain results (objective data). Results will be compared to predicted values based on age, sex, height and weight.
Measured: Up to approximately 1 year
To measure the EQ-5D-5L (Euroscore) to assess general health and correlate this with the primary objective (RFcsa).
EQ5D-5L is a standardised tool that provides a simple generic measure of health. A summation of all the levels will be converted to a single index value using the EQ5D-5L crosswalk index value calculator. The general health score can range from 0 (worst health imaginable) to 100 (best health imaginable). Additionally, a health state ranging from level 1 (indicating no problem) to level 5 (indicating extreme problems) can be calculated using the descriptive system and its five dimensions.
Measured: Up to approximately 1 year
Hospital anxiety and depression score (HADS) to assess HRQoL and correlate this with the overall primary objective (RFcsa).
The HADS is an assessment that measures whether a patient is suffering from anxiety or depression. HADS is a self assessment consisting of 16 items. A result between 0 and 7 indicates a normal case, between 8 and 10 indicates borderline abnormal and between 11 and 21 indicates abnormal levels of anxiety and depression.
Measured: Up to approximately 1 year
Reintegration to normal living index (RNLI) to assess HRQoL and correlate this with the overall primary objective (RFcsa).
The RNLI is a 5 domain 11-tool item aimed at assessing the degree to which patients' who have experienced traumatic and incapacitating illness achieve reintegration into society. The RNLI score is based out of 110, which will be proportionally converted to create a score of 100. Zero indicates no integration whereas 100 implies full integration.
Measured: Up to approximately 1 year
10-item questionnaire to assess HRQoL (pre-morbid functional status) and correlate this with the overall primary objective.
This is a locally devised questionnaire that is answered by the patients' next of kin due to them being incapacitated. We will correlate these results with the other HRQoL questionnaires.
Measured: Day 0 (on admission)
Secondary outcomes (5)
The secondary aim is to understand the molecular profile (bloods).
Blood analysis will contain and analyse but not limited to markers of oxidative stress injury, inflammation, MiRNA and injury to multiple organs will be quantified. We will collect, store and analyse buffy coat and plasma to understand these profiles.
Measured: Up to approximately 1 year
Urine Analysis
Urine analysis measures albumin-creatinine ratio (ACR).
Measured: Up to approximately 1 year
Muscle Biopsy
A muscle biopsy will be taken from patients whilst under anaesthesia. The biopsy observes pathways relevant to muscle homeostasis using biochemical and molecular techniques.
Measured: Intra operatively
Vascular endothelial cell sampling
Cell samples will be acquired from insertion of the central line.
Measured: Day 0.
Cardiac post operative morbidity score (C-POMS) will be used to calculate total morbidity risk.
C-POMS is additional data that will be collected and analysed. C-POMS is a validated tool assessing in-hospital morbidity burden (score 0-13) derived by noting the presence of 13 morbidity domains (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wounds, pain, endocrine, electrolytes, review and assisted ambulation) on days 3, 5, 8 and 15 after cardiac surgery. A higher score indicates a greater morbidity burden. Although ECMO is not considered cardiac surgery we can still utilise C-POMS as a descriptive measure.
Measured: Time Frame: Day 3, day 5, day 8 and day 15 post ECMO initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start9 Apr 2019
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor
- Investigators
- Mark Griffiths, PhD FRCP, Principal investigator, Substantive Employee and primary supervisor to PhD studentJulie Sanders, MSc, PhD, Principal investigator, Director of research and supervisor to PhD studentAshley Thomas, MSc, Principal investigator, Substantive employee and PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753412
- Sponsor's protocol ID
- 012370 CLEVERER
- Acronym
- CLEVERER
- Status last verified
- Jan 2026
- First submitted
- 5 Jun 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bloch SA, Donaldson AV, Lewis A, Banya WA, Polkey MI, Griffiths MJ, Kemp PR. MiR-181a: a potential biomarker of acute muscle wasting following elective high-risk cardiothoracic surgery. Crit Care. 2015 Apr 7;19(1):147. doi: 10.1186/s13054-015-0853-5.
PubMed 25888214
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Regarding the Determinants of Functional Disability and Quality of Life in Patients Recovering From Severe Acute Cardiac or Respiratory Failure Considered for Mechanical Cardiorespiratory Support (CLEVERER)
- ClinicalTrials.gov ID
- NCT03753412
- Acronym / sponsor ID
- CLEVERER / 012370 CLEVERER
- Conditions
- Intensive Care Unit Syndrome, Intensive Care Neuropathy, Intensive Care (ICU) Myopathy, Acute Respiratory Distress Syndrome, Cardiac Failure, Respiratory Failure
- Keywords
- Extra Corporeal Membrane Oxygenation (ECMO), Intensive Care Unit Acquired Weakness (ICUAW), Critical Illness Polyneuromyopathy (CIPM), Ultrasound (US), Health Related Quality of Life (HRQoL)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 27 Nov 2018 (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.
To observe and identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) following a severe cardiorespiratory failure requiring extra-corporeal membrane oxygenation (ECMO). Additionally, to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. CLEVERER is a clinical observational pilot study.
Detailed description
To identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. This phenomenon has become more evident over recent years and still requires extensive research.
ICUAW is an umbrella term for more specifically polyneuropathy and myopathy. Recent research has found that 50% of patients undergoing elective cardiac surgery lose significant muscle mass (9.6% in the wasters group) within the first seven days. These patients are receiving relatively uncomplicated surgery yet still suffering from muscle breakdown, which cannot be described by inactivity alone. The investigators wish to observe ICUAW in a real-life context, however, where cases are always severe. ICUAW can lead to a significant increase in mortality and morbidity. Risk factors for ICUAW include neuromuscular blocking agents, hyperglycaemia, inactivity and sepsis. The correlation between a patient group with severe cardiorespiratory failure and patient-centred outcomes during recovery such as functional ability and health-related quality of life (HRQoL) has been little studied.
Severe cardiac and respiratory failure can both be supported by a mechanical cardio-respiratory support (MCS) including extra-corporeal membrane oxygenation (ECMO); therefore referral for this intervention can be used as a marker of the severest form of cardiorespiratory failure. Both conditions are associated with a high incidence of collateral multi-organ dysfunction and mortality; as well as long-term morbidity, loss of independence and reduced quality of life. Patients with acute cardiac and respiratory failure referred to St Bartholomew's hospital for consideration of MCS will be recruited by advice/guidance from a personal and professional consultee.
Rectus femoris cross-sectional area (RFcsa) will be measured by ultrasound during the first week of admission and at pre-determined time points. The RFcsa will be correlated with indices of muscle strength, physical function and HRQoL. The investigators will also take blood and urine samples on arrival and at pre-defined intervals during the patients' admission for circulating and respiratory markers of sepsis, oxidative stress and organ injury. A muscle biopsy will be taken from the operation field if the patient is centrally cannulated when initiating ECMO.
The primary Objective is to identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after severe cardiorespiratory failure. Specifically, to observe the cross-sectional area of the Rectus Femoris (RFcsa) and correlate this with muscle strength and HRQoL during recovery. RFcsa, hand-held dynamometry, knee straightening dynamometry, Free Fat Mass Index, standing and lying vital capacity, MRC-SS sum score and short physical performance battery (SPPB) will be observed. Also, HRQoL will be measured using the reintegration to normal living index (RNLI), hospital and anxiety depression score (HADS)and the EQ-5D-5L (EuroQol research foundation). Additionally, we have composed a 10 item questionnaire to assess pre-morbid functional status. The primary endpoint will be once all these data are gathered and analysed.
The secondary aim is to understand the molecular and genomic profile of blood samples and the histology of the muscle biopsies. The objective will be supported with additional data from urine analysis (albumin-creatinine ratio) and vascular endothelial cells. The secondary endpoint will be once these data are collected and analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICUAW ECMO group | – | –The physical and psychological effects of ICUAW on patients receiving extracorporeal membrane oxygenation for severe cardiorespiratory failure will be observed. Physical function and HRQoL will be analysed and correlated with RFcsa. Additionally, biological markers will be used to understand molecular and genomic profiles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with severe cardiac or respiratory failure requiring extra-corporeal membrane oxygenation with no pre-existing muscle weakness or wasting.
Key inclusion criteria (3 listed)
- Above the age of 18
- Adults with severe cardio-respiratory failure requiring ECMO.
- Adults who have had personal and professional consultees agree to enrol them in the trial.
Key exclusion criteria (5 listed)
- Previous Stroke
- Neuromuscular disease
- Malignancy
- Underlying neuromuscular disease
- paediatrics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To observe the change in cross sectional area of the Rectus Femoris (RFcsa, measured in cm2) during critical illness and recovery.
Time frame: Up to approximately 1 year.
RFcsa will be calculated using B-mode ultrasound (US) at pre-determined time points. Additionally, the images acquired will have histogram analysis in adobe photoshop software. The RFcsa will be correlated with indices of muscle strength and HRQoL. A larger RFcsa with reduced pixel density suggests greater muscle quality and function.
To Observe a change in Hand Held Dynamometry strength and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Up to approximately 1 year.
Hand-held dynamometry will be calculated using the JAMAR hand-held hydraulic dynamometer. We will assess both hands and take the mean of 3 trials, producing a maximal grip result. A higher score indicates better global strength and function.
To observe a change in Knee straightening dynamometry, strength and joint moment (torque) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Up to approximately 1 year
The test will be conducted using a Lafayette Manual Muscle Tester. Joint knee moment (torque) and strength will be measured. A higher result from joint knee moment and strength indicates a greater global strength and function.
To test the Medical Research Council Sum Score (MRC-SS). MRC-SS measures global strength and ambulation
Time frame: Up to approximately 1 year.
This test will be conducted once to reaffirm whether patients' have ICUAW. A score can range from 0 (paralysis) to 60 (normal strength). A score of less than 48 indicates the patient has ICUAW. Therefore, a lower score is associated with worse outcomes.
To observe a change in Short Physical Performance Battery (SPPB) and correlate this with RFcsa, function and HRQoL during critical illness and recovery
Time frame: Up to approximately 1 year.
SPPB will be used as a further marker of functional status. The patient can score between 0 (poor functional status) and 12 (good functional status).
Lying and Standing Vital Capacity (FVC - forced vital capacity) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Up to approximately 1 year
Lying and standing vital capacity will be measured using a hand held spirometer. The test score will be compared to the predicted normal value based on age, height, race and gender. A result is considered normal if it is 80 percent or more of the predicted value.
To measure a change in Free Fat Mass Index (FFMI) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Up to approximately 1 year
Free fat mass index (FFMI) and free fat mass (FFM) will be measured using the bodystat 1500 device. Other values will also be recorded from the test including body fat percentage and lean mass percentage. The body stat 1500 is an electrical device that uses electrical impedance to obtain results (objective data). Results will be compared to predicted values based on age, sex, height and weight.
To measure the EQ-5D-5L (Euroscore) to assess general health and correlate this with the primary objective (RFcsa).
Time frame: Up to approximately 1 year
EQ5D-5L is a standardised tool that provides a simple generic measure of health. A summation of all the levels will be converted to a single index value using the EQ5D-5L crosswalk index value calculator. The general health score can range from 0 (worst health imaginable) to 100 (best health imaginable). Additionally, a health state ranging from level 1 (indicating no problem) to level 5 (indicating extreme problems) can be calculated using the descriptive system and its five dimensions.
Hospital anxiety and depression score (HADS) to assess HRQoL and correlate this with the overall primary objective (RFcsa).
Time frame: Up to approximately 1 year
The HADS is an assessment that measures whether a patient is suffering from anxiety or depression. HADS is a self assessment consisting of 16 items. A result between 0 and 7 indicates a normal case, between 8 and 10 indicates borderline abnormal and between 11 and 21 indicates abnormal levels of anxiety and depression.
Reintegration to normal living index (RNLI) to assess HRQoL and correlate this with the overall primary objective (RFcsa).
Time frame: Up to approximately 1 year
The RNLI is a 5 domain 11-tool item aimed at assessing the degree to which patients' who have experienced traumatic and incapacitating illness achieve reintegration into society. The RNLI score is based out of 110, which will be proportionally converted to create a score of 100. Zero indicates no integration whereas 100 implies full integration.
10-item questionnaire to assess HRQoL (pre-morbid functional status) and correlate this with the overall primary objective.
Time frame: Day 0 (on admission)
This is a locally devised questionnaire that is answered by the patients' next of kin due to them being incapacitated. We will correlate these results with the other HRQoL questionnaires.
5 secondary outcomes
The secondary aim is to understand the molecular profile (bloods).
Time frame: Up to approximately 1 year
Urine Analysis
Time frame: Up to approximately 1 year
Muscle Biopsy
Time frame: Intra operatively
Vascular endothelial cell sampling
Time frame: Day 0.
Cardiac post operative morbidity score (C-POMS) will be used to calculate total morbidity risk.
Time frame: Time Frame: Day 3, day 5, day 8 and day 15 post ECMO initiation.
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 7 Jan 2026.
- Background: PubMed 25888214Bloch SA, Donaldson AV, Lewis A, Banya WA, Polkey MI, Griffiths MJ, Kemp PR. MiR-181a: a potential biomarker of acute muscle wasting following elective high-risk cardiothoracic surgery. Crit Care. 2015 Apr 7;19(1):147. doi: 10.1186/s13054-015-0853-5.
- Individual participant dataSharing planned: No
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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.
Mark Griffiths, PhD FRCP principal investigator
Substantive Employee and primary supervisor to PhD student
Julie Sanders, MSc, PhD principal investigator
Director of research and supervisor to PhD student
Ashley Thomas, MSc principal investigator
Substantive employee and PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome and Intensive Care Neuropathy, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 5 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 Mark Griffiths, PhD FRCP (07875999126, Mark.griffiths@bartshealth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the change in cross sectional area of the Rectus Femoris (RFcsa, measured in cm2) during critical illness and recovery. (time frame: Up to approximately 1 year.). The study lists 11 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 NCT03753412, which also lists 1 linked publication.
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 7 Jan 2026.