The CONFUCIUS Oral Protein Supplementation Trial (CONFUCIUS)

CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Intensive Care Unit Acquired Weakness
• Intervention / Treatment: Dietary supplement: Porcine protein supplement; Dietary supplement: Control product maltodextrin supplement

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arthur RH van Zanten, MD, PhD; Phone Number: +31 318434115; Email: zantena@zgv.nl
• Study Contact Backup: Name: Yente FN Boelens, MSc; Phone Number: +31 318434117; Email: yboelens@zgv.nl

Study Locations

• Netherlands
  • Gelderland
    • Ede, Gelderland, Netherlands, 6716RP
      • Recruiting
      • Gelderse Vallei Hospital
      • Contact: Arthur RH van Zanten, MD, PhD; Phone Number: +31 318 434115; Email: zantena@zgv.nl
      • Contact: Yente FN Boelens, MSc; Phone Number: +31 318 434117; Email: yboelens@zgv.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Handgrip strength assessed with Jamar dynamometer	6 weeks after ICU discharge (end of the intervention)
Muscle strength leg	Muscle strength leg assessed with handheld dynamometer m. quadriceps fem.	6 weeks after ICU discharge (end of the intervention)
Muscle strength arm	Muscle strength arm assessed with handheld dynamometer m. biceps brachii	6 weeks after ICU discharge (end of the intervention)
Exercise capacity	Exercise capacity assessed with 6 minute walking distance	6 weeks after ICU discharge (end of the intervention)
Lower extremity muscle strength	Lower extremity muscle strength assessed with Timed chair stand test	6 weeks after ICU discharge (end of the intervention)
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
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
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)
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
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
Laboratory evaluation	Plasma aminoacid concentrations	6 weeks after ICU discharge (end intervention)
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
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
Clinical endpoint survival	Overall survival	6 weeks after ICU discharge (end intervention) and 3 months follow-up

Collaborators and Investigators

• Sponsor: Arthur van Zanten
• Collaborators: Rousselot BVBA; Intensive Care Research Foundation, Gelderse Vallei Hospital
• Investigators: Principal Investigator: Arthur RH van Zanten, MD, PhD, Gelderse Vallei Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Intensive care unit; Proteins; Functional outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: NL7915809121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No