Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring ECMO

NCT03026985 | Completed

• 1 other identifier: 516/16
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to describe the changes in quadriceps muscle size and quality over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound imaging. This study will also examine the relationship between those changes and muscle strength and level of physical function at day 10 and day 20 after ECMO commencement.

Conditions

Critical Illness; Muscle Wasting; Extracorporeal Membrane Oxygenation

Keywords

Extracorporeal Membrane Oxygenation; Ultrasonography; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO

  Change in quadriceps muscle size

  10 days

Study Arms (1)

Observational cohort

Ultrasound measurement of quadriceps muscle size and echogenicity will be obtained at baseline (within 48 hours of ECMO commencement), 10 days and 20 days after baseline measurement. Measures of muscle strength and highest mobility level will be obtained at day 10 and day 20 after baseline measurement in order to determine the relationship between these volitional measures and the ultrasound parameters.

Other: Observational cohort

Interventions

Observational cohort OTHER

Ultrasound assessment of quadriceps, muscle strength testing, highest mobility level

Observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients admitted to the ICU requiring ECMO

You may qualify if:

• Adult patients (≥18 years)
• Requiring ECMO for management of severe cardiac or respiratory failure
• Likely to spend \> 24 hours on ECMO

You may not qualify if:

• Presence of:
• Any connective tissue disorders (e.g., Marfan's syndrome)
• A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury after cardiac arrest or asphyxiation
• Any neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, Guillain-Barre syndrome)
• Any current cancer or chemotherapy
• A cognitive impairment prior to the acute illness that is associated with admission to ICU that would impair capacity to follow verbal instructions Any current acute musculoskeletal injuries of hip, knee, and ankle
• A language barrier to patient comprehension, or where death is deemed imminent and inevitable

Sponsors & Collaborators

• The Alfred: lead

Study Sites (1)

Alfred Health

Melbourne, 3181, Australia

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

• Kate Hayes

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 20, 2017
• Study Start: January 25, 2017
• Primary Completion: September 19, 2017
• Study Completion: September 19, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)