The CONFUCIUS Oral Protein Supplementation Trial

Critical Illness Clinical Trial

— CONFUCIUS  

Official title:

CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05405764
• Other study ID #: NL7915809121
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2022
• Source: Gelderse Vallei Hospital
• Contact: Arthur RH van Zanten, MD, PhD
• Phone: 318434115
• Email: zantena[@]zgv.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit Acquired Weakness

Intervention

Dietary Supplement:
• Porcine protein supplement
Porcine protein supplementation
• Control product maltodextrin supplement
Maltodextrin supplementation

Locations

Country	Name	City	State
Netherlands	Gelderse Vallei Hospital	Ede	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Arthur van Zanten	Intensive Care Research Foundation, Gelderse Vallei Hospital, Rousselot BVBA

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At hospital discharge, an average of 11 days
Primary	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.	At the end of the intervention = 6 weeks after ICU discharge
Primary	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.	At 3-months follow-up
Secondary	Handgrip strength	Handgrip strength assessed with Jamar dynamometer	6 weeks after ICU discharge (end of the intervention)
Secondary	Muscle strength leg	Muscle strength leg assessed with handheld dynamometer m. quadriceps fem.	6 weeks after ICU discharge (end of the intervention)
Secondary	Muscle strength arm	Muscle strength arm assessed with handheld dynamometer m. biceps brachii	6 weeks after ICU discharge (end of the intervention)
Secondary	Exercise capacity	Exercise capacity assessed with 6 minute walking distance	6 weeks after ICU discharge (end of the intervention)
Secondary	Lower extremity muscle strength	Lower extremity muscle strength assessed with Timed chair stand test	6 weeks after ICU discharge (end of the intervention)
Secondary	Muscle strength and function (Chelsea Critical Care Physical Assessment Tool)	CPAx is used to score physical morbidity. Score 0-50. The higher the score, the more independent.	At hospital discharge, an average of 11 days
Secondary	Muscle strength and function (Medical Research Council-sumscore)	MRCsum is used to evaluate global muscle strength. Score from 0-60. The higher the score, the better the strength.	At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Secondary	Functional performance	Barthel score. Score 0-20. The higher the score, the more independent. Rockwood Clinical Frailty Scale. Score 1-9. The higher the score, the higher the frailty,	6 weeks after ICU discharge (end intervention)
Secondary	Health related quality of life	Health related quality of life assessed by EuroQol 5D	At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Secondary	Muscle mass	Bio electric impedance analysis	At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Secondary	Laboratory evaluation	Plasma aminoacid concentrations	6 weeks after ICU discharge (end intervention)
Secondary	Clinical endpoint ICU readmission	Number of participants with ICU readmission after ICU discharge	6 weeks after ICU discharge (end intervention) and 3 months follow-up
Secondary	Clinical endpoint hospital readmission	Number of participants with hospital readmission after hospital discharge	6 weeks after ICU discharge (end intervention) and 3 months follow-up
Secondary	Clinical endpoint survival	Overall survival	6 weeks after ICU discharge (end intervention) and 3 months follow-up