Recovery From ICUAW Following Severe Respiratory and Cardiac Failure
NCT ID: NCT03753412
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2019-04-09
2026-09-26
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Adults with severe cardio-respiratory failure requiring ECMO.
* Adults who have had personal and professional consultees agree to enrol them in the trial.
Exclusion Criteria
* Neuromuscular disease
* Malignancy
* Underlying neuromuscular disease
* paediatrics
18 Years
ALL
No
Sponsors
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Queen Mary University of London
OTHER
Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Mark Griffiths, PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
Substantive Employee and primary supervisor to PhD student
Julie Sanders, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Director of research and supervisor to PhD student
Ashley Thomas, MSc
Role: PRINCIPAL_INVESTIGATOR
Substantive employee and PhD student
Locations
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St Bartholomew's hospital (Barts NHS trust)
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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012370 CLEVERER
Identifier Type: -
Identifier Source: org_study_id
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