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

NCT03269825 | Completed

• 1 other identifier: 17/WA/0166
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness; Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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)

• Length of ventilation

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

• Discharge destination

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Danielle E Bear, MRes

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEE / NIHR Clinical Doctoral Fellow and Critical Care Dietitian

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: September 1, 2017
• Study Start: June 20, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)