Clinical trial NCT03269825: The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO
Official title: The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Muscle Atrophy
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Critically ill patients with severe respiratory failure requiring VV-ECMO

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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause mortality
timeFrame: On ECMO (expected to be about 10 days)
Secondary outcomes:
measure: Length of ECMO duration
timeFrame: The total duration on ECMO (expected to be an average of 10 days)
measure: Length of ICU admission
timeFrame: The total duration of ICU admission (expected to be around 2 weeks)
measure: Length of hospital stay
timeFrame: The total duration of hospital admission (expected to be around 28 days)
measure: Length of ventilation
timeFrame: Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
measure: Discharge destination
timeFrame: After discharge from hospital (expected to be around 28 days)
measure: Sequential changes in the muscle quantity over time
timeFrame: The total duration of ECMO (expected to be around 10 days)
measure: Sequential changes in muscle quality over time
timeFrame: The total duration of ECMO (expected to be around 10 days)
measure: Relationship between muscle loss and total nutrition received
timeFrame: The total duration of ECMO (expected to be around 10 days)
measure: Relationship between muscle loss and rehabilitation goals met
timeFrame: The total duration of ECMO (expected to be around 10 days)
measure: All cause mortality
timeFrame: Intensive Care Unit Stay (expected to be about 2 weeks)
measure: All cause mortality
timeFrame: 6 months post-ICU discharge
measure: All cause mortality
timeFrame: Hospital discharge (expected to be about 28 days)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Danielle E Bear, MRes
role: PRINCIPAL_INVESTIGATOR
References: