Clinical trial NCT05405764: The CONFUCIUS Oral Protein Supplementation Trial
Official title: CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Critical Illness
Keywords: Functional outcomes
Proteins
Intensive care unit
Lead sponsor: Gelderse Vallei Hospital
Sponsor class: OTHER
Collaborators: name: Intensive Care Research Foundation, Gelderse Vallei Hospital
name: Rousselot BVBA
First posted: 2022-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel two-arm randomized blinded controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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:

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

Primary outcomes:
measure: Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
timeFrame: At hospital discharge, an average of 11 days
measure: Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
timeFrame: At the end of the intervention = 6 weeks after ICU discharge
measure: Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
timeFrame: At 3-months follow-up
Secondary outcomes:
measure: Handgrip strength
timeFrame: 6 weeks after ICU discharge (end of the intervention)
measure: Muscle strength leg
timeFrame: 6 weeks after ICU discharge (end of the intervention)
measure: Muscle strength arm
timeFrame: 6 weeks after ICU discharge (end of the intervention)
measure: Exercise capacity
timeFrame: 6 weeks after ICU discharge (end of the intervention)
measure: Lower extremity muscle strength
timeFrame: 6 weeks after ICU discharge (end of the intervention)
measure: Muscle strength and function (Chelsea Critical Care Physical Assessment Tool)
timeFrame: At hospital discharge, an average of 11 days
measure: Muscle strength and function (Medical Research Council-sumscore)
timeFrame: At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
measure: Functional performance
timeFrame: 6 weeks after ICU discharge (end intervention)
measure: Health related quality of life
timeFrame: At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
measure: Muscle mass
timeFrame: At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
measure: Laboratory evaluation
timeFrame: 6 weeks after ICU discharge (end intervention)
measure: Clinical endpoint ICU readmission
timeFrame: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
measure: Clinical endpoint hospital readmission
timeFrame: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
measure: Clinical endpoint survival
timeFrame: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: Gelderse Vallei Hospital
state: Gelderland
Study officials:
affiliation: Gelderse Vallei Hospital
name: Arthur RH van Zanten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: