The CONFUCIUS Oral Protein Supplementation Trial

• Sponsor: Arthur van Zanten (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05405764
• Collaborator: Intensive Care Research Foundation, Gelderse Vallei Hospital (Other), Rousselot BVBA (Industry)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.4
• Patients Per Site Per Month: 3

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Unit Acquired Weakness; Critical Illness	Dietary Supplement: Porcine protein supplement; Dietary Supplement: Control product maltodextrin supplement	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel two-arm randomized blinded controlled trialparallel two-arm randomized blinded controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Identical non-transparent sachets with circle or square
• Primary Purpose: Treatment
• Official Title: CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation
• Actual Study Start Date: Apr 19, 2022
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Porcine protein supplement; Porcine protein supplementation
Placebo Comparator: 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.	Dietary Supplement: Control product maltodextrin supplement; Maltodextrin supplementation

Outcome Measures

Primary Outcome Measures

1. Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. [At hospital discharge, an average of 11 days]

   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.

2. Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. [At the end of the intervention = 6 weeks after ICU discharge]

   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.

3. Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. [At 3-months follow-up]

   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.

Secondary Outcome Measures

1. Handgrip strength [6 weeks after ICU discharge (end of the intervention)]

   Handgrip strength assessed with Jamar dynamometer

2. Muscle strength leg [6 weeks after ICU discharge (end of the intervention)]

   Muscle strength leg assessed with handheld dynamometer m. quadriceps fem.

3. Muscle strength arm [6 weeks after ICU discharge (end of the intervention)]

   Muscle strength arm assessed with handheld dynamometer m. biceps brachii

4. Exercise capacity [6 weeks after ICU discharge (end of the intervention)]

   Exercise capacity assessed with 6 minute walking distance

5. Lower extremity muscle strength [6 weeks after ICU discharge (end of the intervention)]

   Lower extremity muscle strength assessed with Timed chair stand test

6. Muscle strength and function (Chelsea Critical Care Physical Assessment Tool) [At hospital discharge, an average of 11 days]

   CPAx is used to score physical morbidity. Score 0-50. The higher the score, the more independent.

7. Muscle strength and function (Medical Research Council-sumscore) [At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up]

   MRCsum is used to evaluate global muscle strength. Score from 0-60. The higher the score, the better the strength.

8. Functional performance [6 weeks after ICU discharge (end intervention)]

   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,

9. Health related quality of life [At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up]

   Health related quality of life assessed by EuroQol 5D

10. Muscle mass [At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up]

    Bio electric impedance analysis

11. Laboratory evaluation [6 weeks after ICU discharge (end intervention)]

    Plasma aminoacid concentrations

12. Clinical endpoint ICU readmission [6 weeks after ICU discharge (end intervention) and 3 months follow-up]

    Number of participants with ICU readmission after ICU discharge

13. Clinical endpoint hospital readmission [6 weeks after ICU discharge (end intervention) and 3 months follow-up]

    Number of participants with hospital readmission after hospital discharge

14. Clinical endpoint survival [6 weeks after ICU discharge (end intervention) and 3 months follow-up]

    Overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gelderse Vallei Hospital	Ede	Gelderland	Netherlands	6716RP

Sponsors and Collaborators

• Arthur van Zanten
• Intensive Care Research Foundation, Gelderse Vallei Hospital
• Rousselot BVBA

Investigators

• Principal Investigator: Arthur RH van Zanten, MD, PhD, Gelderse Vallei Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arthur van Zanten, Prof. Dr. ARH van Zanten, MD, PhD, Gelderse Vallei Hospital
• ClinicalTrials.gov Identifier: NCT05405764
• Other Study ID Numbers: NL7915809121
• First Posted: Jun 6, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Arthur van Zanten, Prof. Dr. ARH van Zanten, MD, PhD, Gelderse Vallei Hospital: Functional outcomes; Proteins; Intensive care unit
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Jun 6, 2022