Critical Illness, Intensive Care Unit Acquired Weakness
Conditions
Keywords
Functional outcomes, Proteins, Intensive care unit
Brief summary
Study the effect of 6-weeks porcine protein supplementation vs isocaloric comparator (carbohydrate) on functional outcomes in post ICU-patients. Patients will be included at ICU discharge. Included patients will receive the supplements twice daily (morning and afternoon), starting at the first day at the general ward. To the best of our knowledge, a study on protein supplementation in the post-ICU period to address its effect on functional outcomes is lacking.
Detailed description
Patients discharged from the Intensive Care Unit frequently suffer from Post Intensive Care Syndrome. This syndrome is characterized by muscle weakness and physical disabilities besides neurocognitive and psychological disturbances. Studies have shown that protein requirements in the post-ICU phase are often not met. Furthermore, protein supplementation in other patient groups have shown beneficial effects. However, a study on protein supplementation during the post-ICU period is lacking. This study aims to investigate the effect of protein supplementation on functional outcomes in post-ICU patients.
Interventions
DIETARY_SUPPLEMENTPorcine protein supplement
Porcine protein supplementation
DIETARY_SUPPLEMENTControl product maltodextrin supplement
Maltodextrin supplementation
Sponsors
Intensive Care Research Foundation, Gelderse Vallei Hospital
Rousselot BVBA
ARH van Zanten
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Identical non-transparent sachets with circle or square
Intervention model description
parallel two-arm randomized blinded controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Chronic home ventilation 4. Mitochondrial or muscle disease or pareses 5. Serum creatinine \> 173 mcmol/l (renal dysfunction) 6. Treatment limitations: DNR, no ICU readmission or palliative care 7. Inclusion in another intervention trial since ICU admission 8. Intolerance or allergy (for study products) 9. People living in a nursing home before hospital admission 10. Chronic Organizing Pneumonia or Pulmonary Interstitial Fibrosis 11. Inflammatory Bowel Disease 12. Diabetes Mellitus pharmaceutical medication at ICU admission 13. Underlying disease in which in the eyes of the attending physician, the protein or carbohydrate supplement could form a risk for the patient. 14. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. | At hospital discharge, an average of 11 days | Between-group difference in physical function over time expressed as a composite score. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. Handgrip strength will be measured with the Jamar dynamometer Muscle strength leg will be measured with the handheld dynamometer m. quadriceps fem. Muscle strength arm will be measured with the handheld dynamometer bicepss brachii Exercise capacity will be measured with the 6 minute walking distance test. Measured values will be compared to normative data. Calculated percentages will be added up and together form the composite score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | 6 weeks after ICU discharge (end of the intervention) | Handgrip strength assessed with Jamar dynamometer |
| Muscle strength leg | 6 weeks after ICU discharge (end of the intervention) | Muscle strength leg assessed with handheld dynamometer m. quadriceps fem. |
| Muscle strength arm | 6 weeks after ICU discharge (end of the intervention) | Muscle strength arm assessed with handheld dynamometer m. biceps brachii |
| Exercise capacity | 6 weeks after ICU discharge (end of the intervention) | Exercise capacity assessed with 6 minute walking distance |
| Lower extremity muscle strength | 6 weeks after ICU discharge (end of the intervention) | Lower extremity muscle strength assessed with Timed chair stand test |
| Muscle strength and function (Chelsea Critical Care Physical Assessment Tool) | At hospital discharge, an average of 11 days | CPAx is used to score physical morbidity. Score 0-50. The higher the score, the more independent. |
| Muscle strength and function (Medical Research Council-sumscore) | At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up | MRCsum is used to evaluate global muscle strength. Score from 0-60. The higher the score, the better the strength. |
| Functional performance | 6 weeks after ICU discharge (end intervention) | Barthel score. Score 0-20. The higher the score, the more independent. Rockwood Clinical Frailty Scale. Score 1-9. The higher the score, the higher the frailty, |
| Health related quality of life | At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up | Health related quality of life assessed by EuroQol 5D |
| Muscle mass | At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up | Bio electric impedance analysis |
| Laboratory evaluation | 6 weeks after ICU discharge (end intervention) | Plasma aminoacid concentrations |
| Clinical endpoint ICU readmission | 6 weeks after ICU discharge (end intervention) and 3 months follow-up | Number of participants with ICU readmission after ICU discharge |
| Clinical endpoint hospital readmission | 6 weeks after ICU discharge (end intervention) and 3 months follow-up | Number of participants with hospital readmission after hospital discharge |
| Clinical endpoint survival | 6 weeks after ICU discharge (end intervention) and 3 months follow-up | Overall survival |
Countries
Netherlands
Outcome results
None listed