Critical Illness
Conditions
Keywords
national support, protein, critical illness
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).
Interventions
DIETARY_SUPPLEMENTa production consist of various oligopeptides and the whey protein
patients will be given extra protein intake except the basic energy intake
DIETARY_SUPPLEMENTbasic energy intake
supplement as basic energy intake
DIETARY_SUPPLEMENTmaltodextrin
used as placebo in the control group
Sponsors
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
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urea nitrogen of 24h | day6 | the total amount of urea nitrogen in 24 hours |
| prealbumin(PA) | day6 | the level of prealbumin in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall complication rate | from the day receiving enteral nutrition to day6 | the over complication rate after receiving enteral nutrition |
| total protein | day6 | the total protein level in blood |
| albumin | day6 | the level of albumin in blood |
| length of hospital stay | from date of admission in the hospital until the date of discharge, up to 1 year | the overall time stay in hospital |
| cost in hospital | from date of admission in the hospital until the date of discharge, up to 1 year | all the money paid in the hospital |
| liver function | day6 | the level of AST/ALT in blood |
| renal function | day6 | the level of creatinine in blood |
| calf circumference | change from baseline calf circumference at 6 days | the perimeter of calf |
| grip | change from baseline grip at 6 days | 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 ) |
Contacts
Primary ContactWei Chen
Backup ContactZhangping Yu
Outcome results
None listed