CONvalescence of FUnCtional outcomes after ICU Stay by oral protein supplementation The CONFUCIUS oral protein supplementation trial

Conditions: na IC opname
intensive care
recovery post-IC

Registration Number: NL-OMON50646

Lead Sponsor: Ziekenhuisvoorzieningen Gelderse Vallei

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

1. Age >= 18 years
2. Living at home before hospital admission
3. Minimum ICU stay of 72 h
4. Informed consent

Exclusion Criteria

1. MRC sum score <= 24 or 48 >= at ICU discharge
2. Barthel Index <14 before ICU admission
3. Allergy/intolerance for study product
4. Serum creatinin > 173 mcmol/l (renal dysfunction)
5. Inclusion in other intervention trial since ICU admission
6. Inflammatory Bowel Disease
7. Zwangerschap
8. Underlying disease in which in the eyes of the attending physician, the
protein or carbohydate supplement could form a risk for the patient

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A composite endpoint of hand grip strength, Hand-held Dynamometer m. quadriceps<br /><br>fem, Hand-held Dynamometer m. biceps brachii and 6 Minute walking test at t=2<br /><br>(hospital discharge), t=3 (day 42 = end of intervention) and t=4 (3 months<br /><br>follow-up).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Handgrip strength assessed with Jamar dynamometer at T=3.<br /><br>- Muscle strength leg assessed with HHD m. quadriceps fem. at T=3.<br /><br>- Muscle strength arm assessed with HHD m. biceps brachii at T=3.<br /><br>- Exercise capacity assessed with 6 Minute Walking Distance at T=3.<br /><br>- Lower extremity muscle function assessed with TCST at T=3.<br /><br>- CPAx at T=2.<br /><br>- MRCsum at T=2, T=3 and T=4.<br /><br>- Barthel score at T=3.<br /><br>- Rockwood Clinical Frailty Scale at T=3.<br /><br>- Body composition (BIA) at T=2, T=3 and T=4.<br /><br>- Plasma AA concentrations at T=3.<br /><br>- ICU readmission after ICU discharge<br /><br>- Hospital readmission after hospital discharge<br /><br>- Overall survival status </p><br>