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The CONFUCIUS Oral Protein Supplementation Trial (CONFUCIUS)

Primary Purpose

Intensive Care Unit Acquired Weakness, Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Porcine protein supplement
Control product maltodextrin supplement
Sponsored by
Arthur van Zanten
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intensive Care Unit Acquired Weakness focused on measuring Functional outcomes, Proteins, Intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gelderse Vallei HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Porcine protein group

Carbohydrate group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Handgrip strength
Handgrip strength assessed with Jamar dynamometer
Muscle strength leg
Muscle strength leg assessed with handheld dynamometer m. quadriceps fem.
Muscle strength arm
Muscle strength arm assessed with handheld dynamometer m. biceps brachii
Exercise capacity
Exercise capacity assessed with 6 minute walking distance
Lower extremity muscle strength
Lower extremity muscle strength assessed with Timed chair stand test
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.
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.
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,
Health related quality of life
Health related quality of life assessed by EuroQol 5D
Muscle mass
Bio electric impedance analysis
Laboratory evaluation
Plasma aminoacid concentrations
Clinical endpoint ICU readmission
Number of participants with ICU readmission after ICU discharge
Clinical endpoint hospital readmission
Number of participants with hospital readmission after hospital discharge
Clinical endpoint survival
Overall survival

Full Information

First Posted
April 13, 2022
Last Updated
June 2, 2022
Sponsor
Arthur van Zanten
Collaborators
Intensive Care Research Foundation, Gelderse Vallei Hospital, Rousselot BVBA
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1. Study Identification

Unique Protocol Identification Number
NCT05405764
Brief Title
The CONFUCIUS Oral Protein Supplementation Trial
Acronym
CONFUCIUS
Official Title
CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arthur van Zanten
Collaborators
Intensive Care Research Foundation, Gelderse Vallei Hospital, Rousselot BVBA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Acquired Weakness, Critical Illness
Keywords
Functional outcomes, Proteins, Intensive care unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel two-arm randomized blinded controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Identical non-transparent sachets with circle or square
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Porcine protein group
Arm Type
Experimental
Arm Description
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.
Arm Title
Carbohydrate group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Porcine protein supplement
Intervention Description
Porcine protein supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Control product maltodextrin supplement
Intervention Description
Maltodextrin supplementation
Primary Outcome Measure Information:
Title
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
Description
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.
Time Frame
At hospital discharge, an average of 11 days
Title
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
Description
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.
Time Frame
At the end of the intervention = 6 weeks after ICU discharge
Title
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
Description
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.
Time Frame
At 3-months follow-up
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Handgrip strength assessed with Jamar dynamometer
Time Frame
6 weeks after ICU discharge (end of the intervention)
Title
Muscle strength leg
Description
Muscle strength leg assessed with handheld dynamometer m. quadriceps fem.
Time Frame
6 weeks after ICU discharge (end of the intervention)
Title
Muscle strength arm
Description
Muscle strength arm assessed with handheld dynamometer m. biceps brachii
Time Frame
6 weeks after ICU discharge (end of the intervention)
Title
Exercise capacity
Description
Exercise capacity assessed with 6 minute walking distance
Time Frame
6 weeks after ICU discharge (end of the intervention)
Title
Lower extremity muscle strength
Description
Lower extremity muscle strength assessed with Timed chair stand test
Time Frame
6 weeks after ICU discharge (end of the intervention)
Title
Muscle strength and function (Chelsea Critical Care Physical Assessment Tool)
Description
CPAx is used to score physical morbidity. Score 0-50. The higher the score, the more independent.
Time Frame
At hospital discharge, an average of 11 days
Title
Muscle strength and function (Medical Research Council-sumscore)
Description
MRCsum is used to evaluate global muscle strength. Score from 0-60. The higher the score, the better the strength.
Time Frame
At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Title
Functional performance
Description
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,
Time Frame
6 weeks after ICU discharge (end intervention)
Title
Health related quality of life
Description
Health related quality of life assessed by EuroQol 5D
Time Frame
At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Title
Muscle mass
Description
Bio electric impedance analysis
Time Frame
At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Title
Laboratory evaluation
Description
Plasma aminoacid concentrations
Time Frame
6 weeks after ICU discharge (end intervention)
Title
Clinical endpoint ICU readmission
Description
Number of participants with ICU readmission after ICU discharge
Time Frame
6 weeks after ICU discharge (end intervention) and 3 months follow-up
Title
Clinical endpoint hospital readmission
Description
Number of participants with hospital readmission after hospital discharge
Time Frame
6 weeks after ICU discharge (end intervention) and 3 months follow-up
Title
Clinical endpoint survival
Description
Overall survival
Time Frame
6 weeks after ICU discharge (end intervention) and 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Living at home before hospital admission Minimum ICU stay of 72 h Informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur RH van Zanten, MD, PhD
Phone
318434115
Ext
+31
Email
zantena@zgv.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Yente FN Boelens, MSc
Phone
318434117
Ext
+31
Email
yboelens@zgv.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur RH van Zanten, MD, PhD
Organizational Affiliation
Gelderse Vallei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gelderse Vallei Hospital
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6716RP
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur RH van Zanten, MD, PhD
Phone
318 434115
Ext
+31
Email
zantena@zgv.nl
First Name & Middle Initial & Last Name & Degree
Yente FN Boelens, MSc
Phone
318 434117
Ext
+31
Email
yboelens@zgv.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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The CONFUCIUS Oral Protein Supplementation Trial

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