eRiCC trial: Early rehabilitation in Critical Care

Recruiting

• Conditions: Intensive care Unit acquired weakness; Sepsis; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12612000528853
• Lead Sponsor: Selina Parry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Individuals expected to be mechanically ventilated for > 48 hours with diagnosis of sepsis or severe sepsis as defined by ACCP Consensus Conference criteria and predicted to remain in ICU for 4 days or more.

Exclusion Criteria

Patients will be excluded if:
1. Known primary systemic neuromuscular disease or intracranial process on ICU admission
2. Lower limb amputation/s
3. Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
4. assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
5. Pregnancy
6. BMI > 40
7. Presence of external fixator or superficial metal in lower limb
8. open wounds or skin abrasions at electrode application points
9. presence of pacemaker or implanted defibrillator
10. transferred from another ICU after > 2 days of mechanical ventilation
11. platelets < 40 000 and INR > 1.6 (for muscle biopsy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle mass and cross sectional area<br><br>Bioimpedance Spectroscopy will be used to evaluate changes in muscle mass. Ultrasonography of the quadriceps will assess changes in muscle thickness and cross sectional area[Baseline and then weekly until ICU discharge, ICU discharge, acute hospital discharge];Muscle Strength<br><br>This will be assessed using the Medical Research Council Scale for identifying muscle weakness in ICU and also hand-held dynamometry for grip strength and isometric quadriceps strength[Baseline, weekly until ICU discharge, ICU Discharge, acute hospital discharge];Physical Function<br><br>This will be assessed using the PFIT (Physical Function Independence Test) and FSS-ICU (Functional Status Score in intensive care). The 6-MWT (six-minute walk test) will be evaluated only at acute hospital discharge[PFIT and FSS-ICU: baseline, weekly in ICU, ICU discharge<br>6-MWT: acute hospital discharge]

Secondary Outcome Measures

Name	Time	Method
Biomarker analyses (muscle biopsy, 24 hour urine collection and blood analyses) in subgroup of n=20 from main pilot RCT[Baseline and ICU discharge];Hours of mechanical ventilation, ICU hours and ICU readmission<br><br>This will be collected from medical records data.[This will all be reported at the completion of the trial]