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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50646
Enrollment
72
Registered
2022-03-17
Start date
2022-04-20
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

na IC opname intensive care recovery post-ICU

Interventions

One group receives daily 2 sachets of 22 g porcine protein, so in total 44 g per day. The other group receives daily 2 sachets of 21 g maltodextrin, so in total 42 g per day.

Sponsors

Ziekenhuisvoorzieningen Gelderse Vallei
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. MRC sum score = at ICU discharge 2. Barthel Index 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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026