The CONFUCIUS Oral Protein Supplementation Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation

Conditions
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Intensive Care Unit Acquired Weakness, Critical Illness

Intervention / Treatment
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* Dietary Supplement: Porcine protein supplement
* Dietary Supplement: Control product maltodextrin supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Living at home before hospital admission Minimum ICU stay of 72 h Informed consent Exclusion Criteria: MRC sum score ≤24 or 48≥ at ICU discharge Barthel Index <14 before ICU admission Chronic home ventilation Mitochondrial or muscle disease or pareses Serum creatinine > 173 mcmol/l (renal dysfunction) Treatment limitations: DNR, no ICU readmission or palliative care Inclusion in another intervention trial since ICU admission Intolerance or allergy (for study products) People living in a nursing home before hospital admission Chronic Organizing Pneumonia or Pulmonary Interstitial Fibrosis Inflammatory Bowel Disease Diabetes Mellitus pharmaceutical medication at ICU admission Underlying disease in which in the eyes of the attending physician, the protein or carbohydrate supplement could form a risk for the patient. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel two-arm randomized blinded controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Porcine protein group<br>The patients will receive protein supplements twice daily (2x22g) for a period of 6 weeks during breakfast and lunch. The supplement will be delivered in powdered form. | Dietary Supplement: Porcine protein supplement<br>* Porcine protein supplementation<br>|
| Placebo Comparator: Carbohydrate group<br>The patients will receive isocaloric carbohydrate supplements twice daily (2x21g) for a period of 6 weeks during morning and afternoon. The supplement will be delivered in powdered form. | Dietary Supplement: Control product maltodextrin supplement<br>* Maltodextrin supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. | 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. | At hospital discharge, an average of 11 days | 
| Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. | 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. | At the end of the intervention = 6 weeks after ICU discharge | 
| Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. | 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. | At 3-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | Handgrip strength assessed with Jamar dynamometer | 6 weeks after ICU discharge (end of the intervention) | 
| Muscle strength leg | Muscle strength leg assessed with handheld dynamometer m. quadriceps fem. | 6 weeks after ICU discharge (end of the intervention) | 
| Muscle strength arm | Muscle strength arm assessed with handheld dynamometer m. biceps brachii | 6 weeks after ICU discharge (end of the intervention) | 
| Exercise capacity | Exercise capacity assessed with 6 minute walking distance | 6 weeks after ICU discharge (end of the intervention) | 
| Lower extremity muscle strength | Lower extremity muscle strength assessed with Timed chair stand test | 6 weeks after ICU discharge (end of the intervention) | 
| Muscle strength and function (Chelsea Critical Care Physical Assessment Tool) | CPAx is used to score physical morbidity. Score 0-50. The higher the score, the more independent. | At hospital discharge, an average of 11 days | 
| Muscle strength and function (Medical Research Council-sumscore) | MRCsum is used to evaluate global muscle strength. Score from 0-60. The higher the score, the better the strength. | At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up | 
| Functional performance | 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, | 6 weeks after ICU discharge (end intervention) | 
| Health related quality of life | Health related quality of life assessed by EuroQol 5D | At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up | 
| Muscle mass | Bio electric impedance analysis | At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up | 
| Laboratory evaluation | Plasma aminoacid concentrations | 6 weeks after ICU discharge (end intervention) | 
| Clinical endpoint ICU readmission | Number of participants with ICU readmission after ICU discharge | 6 weeks after ICU discharge (end intervention) and 3 months follow-up | 
| Clinical endpoint hospital readmission | Number of participants with hospital readmission after hospital discharge | 6 weeks after ICU discharge (end intervention) and 3 months follow-up | 
| Clinical endpoint survival | Overall survival | 6 weeks after ICU discharge (end intervention) and 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional outcomes, Proteins, Intensive care unit