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Clinical Trials/NCT03269825
NCT03269825CompletedNot Applicable

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

Guy's and St Thomas' NHS Foundation Trust1 site in 1 country215 target enrollmentStarted: June 20, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
215
Locations
1
Primary Endpoint
All cause mortality

Study Overview

Brief 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).

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Length of ventilation(Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days))
  • Relationship between muscle loss and total nutrition received(The total duration of ECMO (expected to be around 10 days))
  • All cause mortality(Hospital discharge (expected to be about 28 days))
  • Relationship between muscle loss and rehabilitation goals met(The total duration of ECMO (expected to be around 10 days))
  • Length of ECMO duration(The total duration on ECMO (expected to be an average of 10 days))
  • Length of ICU admission(The total duration of ICU admission (expected to be around 2 weeks))
  • Length of hospital stay(The total duration of hospital admission (expected to be around 28 days))
  • Discharge destination(After discharge from hospital (expected to be around 28 days))
  • Sequential changes in the muscle quantity over time(The total duration of ECMO (expected to be around 10 days))
  • Sequential changes in muscle quality over time(The total duration of ECMO (expected to be around 10 days))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Danielle Bear

HEE / NIHR Clinical Doctoral Fellow and Critical Care Dietitian

Guy's and St Thomas' NHS Foundation Trust

Study Sites (1)

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