The CONFUCIUS Oral Protein Supplementation Trial

ARH van Zanten15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Intensive Care Unit Acquired Weakness Critical Illness

Interventions

Porcine protein supplementDIETARY_SUPPLEMENT

Porcine protein supplementation

Control product maltodextrin supplementDIETARY_SUPPLEMENT

Maltodextrin supplementation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Gelderse Vallei Hospital

Ede, Gelderland, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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