Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

Recovery From ICUAW Following Severe Respiratory and Cardiac Failure

Sponsor: Barts & The London NHS Trust

NCT ID: NCT03753412

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 89 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
100
Started
2019-04-09
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for intensive care unit syndrome
  • • Clinical study - 100 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with intensive care unit syndrome

Where?

  • • London - St Bartholomew's hospital (Barts NHS trust)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Intensive Care Unit SyndromeIntensive Care NeuropathyIntensive Care (ICU) MyopathyAcute Respiratory Distress SyndromeCardiac FailureRespiratory FailureCritical Illness Myopathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 take part

  • ✗Previous Stroke
  • ✗Neuromuscular disease
  • ✗cancer
  • ✗Underlying neuromuscular disease
  • ✗paediatrics
See the full criteria
Inclusion Criteria: * 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. Exclusion criteria: * Previous Stroke * Neuromuscular disease * Malignancy * Underlying neuromuscular disease * paediatrics

Where Is This Study? (1 UK site)

St Bartholomew's hospital (Barts NHS trust)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Griffiths, Mark Griffiths, FRCP, PhDPrincipal Investigator
Griffiths, Mark Griffiths, FRRCP, PhD447875999126Mark.Griffiths@bartshealth.nhs.uk

How to Get in Touch

Mark Griffiths, PhD FRCP

Sponsor contact

CONTACT

07875999126 Mark.griffiths@bartshealth.nhs.uk

Ashley Thomas, MSc

Sponsor contact

CONTACT

07597875857 ashleythomas@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-01