Intensive Care Unit Acquired WeaknessCONFUCIUSNCT05405764
The CONFUCIUS Oral Protein Supplementation Trial
A study testing Porcine protein supplement in people with Intensive Care Unit Acquired Weakness and Critical Illness, run by ARH van Zanten at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Critical Illness
- What is being tested?
- Porcine protein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Apr 2022to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Living at home before hospital admission
- Minimum ICU stay of 72 h
- Informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Porcine protein supplement, Control product maltodextrin supplement
- Keywords
- Functional outcomes, Proteins, Intensive care unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine protein supplementDietary supplement
Porcine protein supplementation
Control product maltodextrin supplementDietary supplement
Maltodextrin supplementation
| Study group | Role | What they receive |
|---|---|---|
| Porcine protein group | Experimental | 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. Receives: Dietary Supplement: Porcine protein supplement |
| Carbohydrate group | Placebo comparator | 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. Receives: Dietary Supplement: Control product maltodextrin supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 3-months follow-up
Secondary outcomes (14)
Handgrip strength
Handgrip strength assessed with Jamar dynamometer
Measured: 6 weeks after ICU discharge (end of the intervention)
Muscle strength leg
Muscle strength leg assessed with handheld dynamometer m. quadriceps fem.
Measured: 6 weeks after ICU discharge (end of the intervention)
Muscle strength arm
Muscle strength arm assessed with handheld dynamometer m. biceps brachii
Measured: 6 weeks after ICU discharge (end of the intervention)
Exercise capacity
Exercise capacity assessed with 6 minute walking distance
Measured: 6 weeks after ICU discharge (end of the intervention)
Lower extremity muscle strength
Lower extremity muscle strength assessed with Timed chair stand test
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 6 weeks after ICU discharge (end intervention)
Health related quality of life
Health related quality of life assessed by EuroQol 5D
Measured: 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
Measured: 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
Measured: 6 weeks after ICU discharge (end intervention)
Clinical endpoint ICU readmission
Number of participants with ICU readmission after ICU discharge
Measured: 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
Measured: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Clinical endpoint survival
Overall survival
Measured: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start19 Apr 2022
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Why it stopped: Slow inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel two-arm randomized blinded controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARH van Zanten
- Sponsor type
- University, hospital or other
- Collaborators
- Intensive Care Research Foundation, Gelderse Vallei Hospital, Rousselot BVBA
- Responsible party
- Sponsor-investigator, ARH van Zanten, Gelderse Vallei Hospital
- Investigators
- Arthur RH van Zanten, MD, PhD, Principal investigator, Gelderse Vallei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405764
- Sponsor's protocol ID
- NL7915809121
- Acronym
- CONFUCIUS
- Status last verified
- Sep 2024
- First submitted
- 13 Apr 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paulus MC, Kouw IWK, Boelens YFN, Hermans AJH, Strookappe B, van Zanten ARH. Feasibility challenges in protein supplementation research: Insights from the convalescence of functional outcomes after intensive care unit stay in a Randomised Controlled Trial. Clin Nutr. 2025 Mar;46:119-130. doi: 10.1016/j.clnu.2025.01.020. Epub 2025 Jan 21.
PubMed 39914233Boelens YF, Strookappe B, Vasse E, Mensink M, van Zanten AR. The effect of an intervention of porcine protein versus maltodextrin supplement on CONvalescence of FUnCtional outcomes after IcU Stay (CONFUCIUS): Study protocol for a randomized controlled, single-center, double-blind trial. Clin Nutr ESPEN. 2022 Dec;52:86-93. doi: 10.1016/j.clnesp.2022.10.008. Epub 2022 Oct 19.
PubMed 36513490
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation
- ClinicalTrials.gov ID
- NCT05405764
- Acronym / sponsor ID
- CONFUCIUS / NL7915809121
- Keywords
- Functional outcomes, Proteins, Intensive care unit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow inclusion rate
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ARH van ZantenUniversity, hospital or other
- Collaborators
- Intensive Care Research Foundation, Gelderse Vallei Hospital, Rousselot BVBA
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel two-arm randomized blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| Porcine protein group | Experimental | Dietary Supplement: Porcine protein supplementThe 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. |
| Carbohydrate group | Placebo comparator | Dietary Supplement: Control product maltodextrin supplementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Living at home before hospital admission
- Minimum ICU stay of 72 h
- Informed consent
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porcine protein supplementPorcine protein supplementation | Dietary supplement | Porcine protein group |
| Control product maltodextrin supplementMaltodextrin supplementation | Dietary supplement | Carbohydrate group |
Primary outcome
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
Time frame: 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.
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
Time frame: 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.
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
Time frame: 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.
14 secondary outcomes
Handgrip strength
Time frame: 6 weeks after ICU discharge (end of the intervention)
Muscle strength leg
Time frame: 6 weeks after ICU discharge (end of the intervention)
Muscle strength arm
Time frame: 6 weeks after ICU discharge (end of the intervention)
Exercise capacity
Time frame: 6 weeks after ICU discharge (end of the intervention)
Lower extremity muscle strength
Time frame: 6 weeks after ICU discharge (end of the intervention)
Muscle strength and function (Chelsea Critical Care Physical Assessment Tool)
Time frame: At hospital discharge, an average of 11 days
Muscle strength and function (Medical Research Council-sumscore)
Time frame: At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Functional performance
Time frame: 6 weeks after ICU discharge (end intervention)
Health related quality of life
Time frame: At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Muscle mass
Time frame: At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Laboratory evaluation
Time frame: 6 weeks after ICU discharge (end intervention)
Clinical endpoint ICU readmission
Time frame: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Clinical endpoint hospital readmission
Time frame: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Clinical endpoint survival
Time frame: 6 weeks after ICU discharge (end intervention) and 3 months follow-up
Results and safety
The study was stopped early (reason given: Slow inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 39914233Paulus MC, Kouw IWK, Boelens YFN, Hermans AJH, Strookappe B, van Zanten ARH. Feasibility challenges in protein supplementation research: Insights from the convalescence of functional outcomes after intensive care unit stay in a Randomised Controlled Trial. Clin Nutr. 2025 Mar;46:119-130. doi: 10.1016/j.clnu.2025.01.020. Epub 2025 Jan 21.
- Derived from this study: PubMed 36513490Boelens YF, Strookappe B, Vasse E, Mensink M, van Zanten AR. The effect of an intervention of porcine protein versus maltodextrin supplement on CONvalescence of FUnCtional outcomes after IcU Stay (CONFUCIUS): Study protocol for a randomized controlled, single-center, double-blind trial. Clin Nutr ESPEN. 2022 Dec;52:86-93. doi: 10.1016/j.clnesp.2022.10.008. Epub 2022 Oct 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur RH van Zanten, MD, PhD principal investigator
Gelderse Vallei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Porcine protein supplement in people with Intensive Care Unit Acquired Weakness and Critical Illness, run by ARH van Zanten at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. (time frame: At hospital discharge, an average of 11 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405764, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.