Status:
TERMINATED
The CONFUCIUS Oral Protein Supplementation Trial
Lead Sponsor:
ARH van Zanten
Collaborating Sponsors:
Intensive Care Research Foundation, Gelderse Vallei Hospital
Rousselot BVBA
Conditions:
Intensive Care Unit Acquired Weakness
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
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 pa...
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...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Living at home before hospital admission
- Minimum ICU stay of 72 h
- Informed consent
Exclusion
- MRC sum score ≤24 or 48≥ at ICU discharge
- Barthel Index \<14 before ICU admission
- Chronic home ventilation
- Mitochondrial or muscle disease or pareses
- Serum creatinine \> 173 mcmol/l (renal dysfunction)
- Treatment limitations: DNR, no ICU readmission or palliative care
- Inclusion in another intervention trial since ICU admission
- Intolerance or allergy (for study products)
- People living in a nursing home before hospital admission
- Chronic Organizing Pneumonia or Pulmonary Interstitial Fibrosis
- Inflammatory Bowel Disease
- Diabetes Mellitus pharmaceutical medication at ICU admission
- Underlying disease in which in the eyes of the attending physician, the protein or carbohydrate supplement could form a risk for the patient.
- Pregnancy
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05405764
Start Date
April 19 2022
End Date
September 24 2024
Last Update
September 25 2024
Active Locations (1)
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1
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands, 6716RP