A Study About Nutritional Support of Enhanced Protein in Critical Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Multicenter Randomized Controlled Clinical Study With WeiYuan Tai (a Nutritional Supplement) on Nutritional Support of Enhanced Protein in Severe Patients(Tai Shan)

Conditions
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Critical Illness

Intervention / Treatment
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* Dietary Supplement: a production consist of various oligopeptides and the whey protein
* Dietary Supplement: basic energy intake
* Dietary Supplement: maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo | Dietary Supplement: basic energy intake<br>* supplement as basic energy intake<br>Dietary Supplement: maltodextrin<br>* used as placebo in the control group<br>|
| Experimental: intervention group<br>Patients will be given basic energy intake according to their weight, and will be extra protein intake | Dietary Supplement: a production consist of various oligopeptides and the whey protein<br>* patients will be given extra protein intake except the basic energy intake<br>Dietary Supplement: basic energy intake<br>* supplement as basic energy intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urea nitrogen of 24h | the total amount of urea nitrogen in 24 hours | day6 | 
| prealbumin(PA) | the level of prealbumin in blood | day6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total protein | the total protein level in blood | day6 | 
| albumin | the level of albumin in blood | day6 | 
| calf circumference | the perimeter of calf | 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 ) | change from baseline grip at 6 days | 
| overall complication rate | the over complication rate after receiving enteral nutrition | from the day receiving enteral nutrition to day6 | 
| length of hospital stay | the overall time stay in hospital | 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 | 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 | day6 | 
| renal function | the level of creatinine in blood | day6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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national support, protein, critical illness