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Critical IllnessNCT03269825

The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO

An observational study of Critical Illness and Muscle Atrophy, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a retrospective, observational study and will investigate the clinical predictive value of and change in muscle quantity and quality in critically ill patients with severe respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Critical Illness, Muscle Atrophy
How many people
215 participants
Where
1 siteUnited Kingdom
Study dates
20 Jun 2017to 31 May 2018
Phase
Observational
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 to 100 years
  • All sexes
  • Adult, Older adult

Study population: Adult Critically ill patients with severe respiratory failure requiring VV-ECMO

Who may be able to join

  • Critically ill patients with Severe Respiratory Failure who required VV-ECMO and had one or more CT scans of their abdomen

Who cannot join

  • Critically ill patients with Severe Respiratory Failure who required VV-ECMO and did not have one or more CT scans of their abdomen
  • Critically ill patients with Severe Respiratory Failure who required VV-ECMO who have a poor quality CT scan not analysable by the software

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH

Other trials in United Kingdom

About this study

This is a retrospective, observational study and will investigate the clinical predictive value of and change in muscle quantity and quality in critically ill patients with severe respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).

Read the detailed description

The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory failure - mainly hypoxaemia - has increased over recent years. Similar to the general population in the Intensive Care Unit (ICU), these patients become deconditioned, severely weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this specific group is lacking.

Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest, abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of different muscle groups of the abdomen at admission and then using any follow-up CT scan performed within 10 days. In addition, the relationship between the loss of muscle over the course of VV-ECMO and perceived recovery of renal function at ICU discharge will be investigated.

Medical subject headings
Critical Illness, Muscular Atrophy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: On ECMO (expected to be about 10 days)

Secondary outcomes (12)

  1. Length of ECMO duration

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: The total duration on ECMO (expected to be an average of 10 days)

  2. Length of ICU admission

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: The total duration of ICU admission (expected to be around 2 weeks)

  3. Length of hospital stay

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: The total duration of hospital admission (expected to be around 28 days)

  4. Length of ventilation

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)

  5. Discharge destination

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: After discharge from hospital (expected to be around 28 days)

  6. Sequential changes in the muscle quantity over time

    Using total muscle quantity measured from CT slice of the third lumbar region.

    Measured: The total duration of ECMO (expected to be around 10 days)

  7. Sequential changes in muscle quality over time

    Using total muscle quality measured from CT slice of the third lumbar region.

    Measured: The total duration of ECMO (expected to be around 10 days)

  8. Relationship between muscle loss and total nutrition received

    Using total muscle quantity measured from CT slice of the third lumbar region.

    Measured: The total duration of ECMO (expected to be around 10 days)

  9. Relationship between muscle loss and rehabilitation goals met

    Using total muscle quantity measured from CT slice of the third lumbar region.

    Measured: The total duration of ECMO (expected to be around 10 days)

  10. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: Intensive Care Unit Stay (expected to be about 2 weeks)

  11. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: 6 months post-ICU discharge

  12. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Measured: Hospital discharge (expected to be about 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2017
  2. Study start20 Jun 2017
  3. Primary completion31 May 2018
  4. Study completion31 May 2018

Resources

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
Retrospective
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03269825
Sponsor's protocol ID
17/WA/0166
Status last verified
Feb 2019
First submitted
23 Jun 2017
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Muscle Atrophy, run by Guy's and St Thomas' NHS Foundation 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 1 inclusion and 2 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 15 Feb 2019. 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?

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?

All cause mortality (time frame: On ECMO (expected to be about 10 days)). 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 NCT03269825.

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 15 Feb 2019.

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