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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269825
• Other study ID #: 17/WA/0166
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: February 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Critical Illness
• Muscle Atrophy
• Muscular Atrophy

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	On ECMO (expected to be about 10 days)
Secondary	Length of ECMO duration	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	The total duration on ECMO (expected to be an average of 10 days)
Secondary	Length of ICU admission	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	The total duration of ICU admission (expected to be around 2 weeks)
Secondary	Length of hospital stay	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	The total duration of hospital admission (expected to be around 28 days)
Secondary	Length of ventilation	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
Secondary	Discharge destination	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	After discharge from hospital (expected to be around 28 days)
Secondary	Sequential changes in the muscle quantity over time	Using total muscle quantity measured from CT slice of the third lumbar region.	The total duration of ECMO (expected to be around 10 days)
Secondary	Sequential changes in muscle quality over time	Using total muscle quality measured from CT slice of the third lumbar region.	The total duration of ECMO (expected to be around 10 days)
Secondary	Relationship between muscle loss and total nutrition received	Using total muscle quantity measured from CT slice of the third lumbar region.	The total duration of ECMO (expected to be around 10 days)
Secondary	Relationship between muscle loss and rehabilitation goals met	Using total muscle quantity measured from CT slice of the third lumbar region.	The total duration of ECMO (expected to be around 10 days)
Secondary	All cause mortality	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	Intensive Care Unit Stay (expected to be about 2 weeks)
Secondary	All cause mortality	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	6 months post-ICU discharge
Secondary	All cause mortality	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	Hospital discharge (expected to be about 28 days)