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Completed

NCT Number: NCT03269825

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

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).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: On ECMO (expected to be about 10 days)

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

Secondary outcomes

  1. Length of ECMO duration

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

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

  2. Length of ICU admission

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

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

  3. Length of hospital stay

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

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

  4. Length of ventilation

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

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

  5. Discharge destination

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

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

  6. Sequential changes in the muscle quantity over time

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

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

  7. Sequential changes in muscle quality over time

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

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

  8. Relationship between muscle loss and total nutrition received

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

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

  9. Relationship between muscle loss and rehabilitation goals met

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

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

  10. All cause mortality

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

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

  11. All cause mortality

    Time frame: 6 months post-ICU discharge

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

  12. All cause mortality

    Time frame: Hospital discharge (expected to be about 28 days)

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

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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