The CONFUCIUS Oral Protein Supplementation Trial

ARH van Zanten

Status: Terminated

Conditions: Intensive Care Unit Acquired Weakness; Critical Illness

Treatments: Dietary Supplement: Control product maltodextrin supplement; Dietary Supplement: Porcine protein supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05405764

NL7915809121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Porcine protein group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Porcine protein supplement

Carbohydrate group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control product maltodextrin supplement