NCT05405764

The CONFUCIUS Oral Protein Supplementation Trial

CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: ARH van Zanten · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intensive Care Unit Acquired Weakness
• Critical Illness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Porcine protein supplement	Porcine protein supplementation
DIETARY_SUPPLEMENT	Control product maltodextrin supplement	Maltodextrin supplementation

Timeline

• Start date: 2022-04-19
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2022-06-06
• Last updated: 2024-09-25

Locations

1 site across 1 country: Netherlands