The CONFUCIUS Oral Protein Supplementation Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2024-09-24

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.

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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.

Conditions

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Intensive Care Unit Acquired Weakness Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel two-arm randomized blinded controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Identical non-transparent sachets with circle or square

Study Groups

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Porcine protein group

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.

Group Type EXPERIMENTAL

Porcine protein supplement

Intervention Type DIETARY_SUPPLEMENT

Porcine protein supplementation

Carbohydrate group

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.

Group Type PLACEBO_COMPARATOR

Control product maltodextrin supplement

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin supplementation

Interventions

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Porcine protein supplement

Porcine protein supplementation

Intervention Type DIETARY_SUPPLEMENT

Control product maltodextrin supplement

Maltodextrin supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No