Serum activin, gene expression, muscle mass and function in people with critical illness (SAGE-MUSCLE): an observational cohort study

Not Applicable

Completed

• Conditions: Intensive Care Unit Aquired Weakness; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12615000047594
• Lead Sponsor: Footscray Hospital Western Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-21
• Study Completion: 2018-12-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Have invasive mechanical ventilation for at least 48 hours and;
Are expected to be in ICU for at least 120 hours

Exclusion Criteria

Aged < 18;
They have a proven or suspected acute primary neurological process likely to result in global impairment of conscious level/cognition or prolonged weakness or;
Death is deemed imminent or inevitable.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum activin level[Daily until discharge from ICU];Needle muscle biopsy of the quadriceps with ultrasound guidance will be required to allow extraction of RNA. Target genes will be analysed by reverse transcription polymerase chain reaction (RT-PCR).[120 hours after admission to ICU];Six-Minute Walk test[On acute hospital discharge]

Secondary Outcome Measures

Name	Time	Method
Grip Strength measured with a hand held dynamometer.[On awakening; first standing occasion; discharge to ward and discharge from acute hospital.];Knee extension strength knee measured using Medical Research Council Scale for manual muscle testing.[On awakening; first standing occasion; discharge to ward and discharge from acute hospital.];Timed Up and Go Test.[On acute hospital discharge.];Physical Function in ICU test (PFIT)[On first standing occasion and on discharge to ward];Discharge destination[On discharge from acute hospital];ICU length of stay[On discharge from ICU];Hospital length of stay[On discharge from acute hospital]