Critical IllnessNCT04177446
A Study About Nutritional Support of Enhanced Protein in Critical Patients
A study testing a production consist of various oligopeptides and the whey protein, basic energy intake and maltodextrin in people with Critical Illness, run by Peking Union Medical College Hospital.
Trial summary
This is a prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- a production consist of various oligopeptides and the whey protein, basic energy intake and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2019to May 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as critical illness, stayed in ICU;
- score of M-nutric ≥ 5;
- score of 3. APACHE Ⅱ >12;
- anticipation of length of hospital stay > 6 days;
- 18 ≤ age ≤ 45;
- pattens volunteer to attend this study and sigh the inform consent form;
Who cannot join
- liver function(AST/ALT) of blood test ≥ 2.5 ULN(upper limit of normal); renal function of blood test > 1.6 ULN;
- the patients are used or are planned to use the Human Albumin solution within 3 days before receiving enteral nutrition;
- consume any natural food or something made by natural food;
- patients are used or are planned to use all-in-one solution or amino acid solution within 3 days before receiving enteral nutrition;
- anticipation of survival time is less than 5 days;
- have the contraindications of enteral nutrition;
- patients are allergic to material of the production;
- patients who are considered not suitable for this study by investigators;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Randomized Controlled Clinical Study With WeiYuan Tai (a Nutritional Supplement) on Nutritional Support of Enhanced Protein in Severe Patients(Tai Shan)
This is a prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status, safety indicators and clinical indicators.
Read the detailed description
Critical illness patients are commonly in the risk of malnutrition, because of various factors. And nutritional supplement, particularly the supplement of protein, can decrease the nitrogen balance, improve the nutritional status, accelerate the speed of healing and decrease the mortality rate. This is a multi center prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status(total protein, albumin, grip and calf circumference), safety indicators(liver function, kidney function, tolerance, etc.) and clinical indicators(overall complication rate, length of hospital stay and cost).
- Conditions
- Critical Illness
- Being tested
- a production consist of various oligopeptides and the whey protein, basic energy intake, maltodextrin
- Keywords
- national support, protein, critical illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a production consist of various oligopeptides and the whey proteinDietary supplement
patients will be given extra protein intake except the basic energy intake
basic energy intakeDietary supplement
supplement as basic energy intake
maltodextrinDietary supplement
used as placebo in the control group
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo Receives: Dietary Supplement: basic energy intake; Dietary Supplement: maltodextrin |
| intervention group | Experimental | Patients will be given basic energy intake according to their weight, and will be extra protein intake Receives: Dietary Supplement: a production consist of various oligopeptides and the whey protein; Dietary Supplement: basic energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
urea nitrogen of 24h
the total amount of urea nitrogen in 24 hours
Measured: day6
prealbumin(PA)
the level of prealbumin in blood
Measured: day6
Secondary outcomes (9)
total protein
the total protein level in blood
Measured: day6
albumin
the level of albumin in blood
Measured: day6
calf circumference
the perimeter of calf
Measured: change from baseline calf circumference at 6 days
grip
the strength(force measured kilograms) of the right hand measured by a hand-held dynamometer (if the right hand is not impossible, the left is ok )
Measured: change from baseline grip at 6 days
overall complication rate
the over complication rate after receiving enteral nutrition
Measured: from the day receiving enteral nutrition to day6
length of hospital stay
the overall time stay in hospital
Measured: from date of admission in the hospital until the date of discharge, up to 1 year
cost in hospital
all the money paid in the hospital
Measured: from date of admission in the hospital until the date of discharge, up to 1 year
liver function
the level of AST/ALT in blood
Measured: day6
renal function
the level of creatinine in blood
Measured: day6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start25 Dec 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yabao Pharmaceutical Group, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, Wei Chen, Peking Union Medical College Hospital
- Investigators
- Wei Chen, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177446
- Sponsor's protocol ID
- HS-2028
- Status last verified
- Dec 2019
- First submitted
- 11 Oct 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data will be shared at the end of the study: demographic data, other baseline data of patients and date of outcomes collected at this research
Publications
Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
PubMed 30348463Arabi YM, Al-Dorzi HM, Mehta S, Tamim HM, Haddad SH, Jones G, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L, Kumar A, Bagshaw SM, Aldawood AS; PermiT Trial Group. Association of protein intake with the outcomes of critically ill patients: a post hoc analysis of the PermiT trial. Am J Clin Nutr. 2018 Nov 1;108(5):988-996. doi: 10.1093/ajcn/nqy189.
PubMed 30475959
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Clinical Study With WeiYuan Tai (a Nutritional Supplement) on Nutritional Support of Enhanced Protein in Severe Patients(Tai Shan)
- ClinicalTrials.gov ID
- NCT04177446
- Acronym / sponsor ID
- HS-2028
- Conditions
- Critical Illness
- Keywords
- national support, protein, critical illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Yabao Pharmaceutical Group, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University
- Study start
- 25 Dec 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 26 Nov 2019 (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.
This is a prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status, safety indicators and clinical indicators.
Detailed description
Critical illness patients are commonly in the risk of malnutrition, because of various factors. And nutritional supplement, particularly the supplement of protein, can decrease the nitrogen balance, improve the nutritional status, accelerate the speed of healing and decrease the mortality rate. This is a multi center prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status(total protein, albumin, grip and calf circumference), safety indicators(liver function, kidney function, tolerance, etc.) and clinical indicators(overall complication rate, length of hospital stay and cost).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Dietary Supplement: basic energy intake, Dietary Supplement: maltodextrinPatients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo |
| intervention group | Experimental | Dietary Supplement: a production consist of various oligopeptides and the whey protein, Dietary Supplement: basic energy intakePatients will be given basic energy intake according to their weight, and will be extra protein intake |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed as critical illness, stayed in ICU;
- score of M-nutric ≥ 5;
- score of 3. APACHE Ⅱ >12;
- anticipation of length of hospital stay > 6 days;
- 18 ≤ age ≤ 45;
Key exclusion criteria (8 listed)
- liver function(AST/ALT) of blood test ≥ 2.5 ULN(upper limit of normal); renal function of blood test > 1.6 ULN;
- the patients are used or are planned to use the Human Albumin solution within 3 days before receiving enteral nutrition;
- consume any natural food or something made by natural food;
- patients are used or are planned to use all-in-one solution or amino acid solution within 3 days before receiving enteral nutrition;
- anticipation of survival time is less than 5 days;
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 |
|---|---|---|
| a production consist of various oligopeptides and the whey proteinpatients will be given extra protein intake except the basic energy intake | Dietary supplement | intervention group |
| basic energy intakesupplement as basic energy intake | Dietary supplement | control group, intervention group |
| maltodextrinused as placebo in the control group | Dietary supplement | control group |
Primary outcome
urea nitrogen of 24h
Time frame: day6
the total amount of urea nitrogen in 24 hours
prealbumin(PA)
Time frame: day6
the level of prealbumin in blood
9 secondary outcomes
total protein
Time frame: day6
albumin
Time frame: day6
calf circumference
Time frame: change from baseline calf circumference at 6 days
grip
Time frame: change from baseline grip at 6 days
overall complication rate
Time frame: from the day receiving enteral nutrition to day6
length of hospital stay
Time frame: from date of admission in the hospital until the date of discharge, up to 1 year
cost in hospital
Time frame: from date of admission in the hospital until the date of discharge, up to 1 year
liver function
Time frame: day6
renal function
Time frame: day6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Results publication: PubMed 30348463Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
- Results publication: PubMed 30475959Arabi YM, Al-Dorzi HM, Mehta S, Tamim HM, Haddad SH, Jones G, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L, Kumar A, Bagshaw SM, Aldawood AS; PermiT Trial Group. Association of protein intake with the outcomes of critically ill patients: a post hoc analysis of the PermiT trial. Am J Clin Nutr. 2018 Nov 1;108(5):988-996. doi: 10.1093/ajcn/nqy189.
- Individual participant dataSharing planned: Yes. The following data will be shared at the end of the study: demographic data, other baseline data of patients and date of outcomes collected at this research
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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.
Wei Chen principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing a production consist of various oligopeptides and the whey protein, basic energy intake and maltodextrin in people with Critical Illness, run by Peking Union Medical College Hospital.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Chen (+86(010)69154095, chenw@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urea nitrogen of 24h (time frame: day6). The study lists 2 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 NCT04177446, 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 20 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.