Clinical trial NCT04177446: A Study About Nutritional Support of Enhanced Protein in Critical Patients
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Keywords: national support
protein
critical illness
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Yabao Pharmaceutical Group
name: The First Affiliated Hospital of Dalian Medical University
name: The Second Affiliated Hospital of Dalian Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2019-11-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

1. diagnosed as critical illness, stayed in ICU;
2. score of M-nutric ≥ 5;
3. score of 3. APACHE Ⅱ \>12;
4. anticipation of length of hospital stay \> 6 days;
5. 18 ≤ age ≤ 45;
6. pattens volunteer to attend this study and sigh the inform consent form;

Exclusion Criteria:

1. liver function(AST/ALT) of blood test ≥ 2.5 ULN(upper limit of normal); renal function of blood test \> 1.6 ULN;
2. the patients are used or are planned to use the Human Albumin solution within 3 days before receiving enteral nutrition;
3. consume any natural food or something made by natural food;
4. patients are used or are planned to use all-in-one solution or amino acid solution within 3 days before receiving enteral nutrition;
5. anticipation of survival time is less than 5 days;
6. have the contraindications of enteral nutrition;
7. patients are allergic to material of the production;
8. patients who are considered not suitable for this study by investigators;

Primary outcomes:
measure: urea nitrogen of 24h
timeFrame: day6
measure: prealbumin(PA)
timeFrame: day6
Secondary outcomes:
measure: total protein
timeFrame: day6
measure: albumin
timeFrame: day6
measure: calf circumference
timeFrame: change from baseline calf circumference at 6 days
measure: grip
timeFrame: change from baseline grip at 6 days
measure: overall complication rate
timeFrame: from the day receiving enteral nutrition to day6
measure: length of hospital stay
timeFrame: from date of admission in the hospital until the date of discharge, up to 1 year
measure: cost in hospital
timeFrame: from date of admission in the hospital until the date of discharge, up to 1 year
measure: liver function
timeFrame: day6
measure: renal function
timeFrame: day6
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wei Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Arabi 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.