Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yabao Pharmaceutical Group | INDUSTRY |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo |
|
| intervention group | Experimental | Patients will be given basic energy intake according to their weight, and will be extra protein intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a production consist of various oligopeptides and the whey protein | Dietary Supplement | patients will be given extra protein intake except the basic energy intake |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| total protein | the total protein level in blood | day6 |
| albumin | the level of albumin in blood | day6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Chen | Contact | +86(010)69154095 | chenw@pumch.cn | |
| Zhangping Yu | Contact | +86(010)69154095 | yuzhangping1993@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Chen | Peking Union Medical College Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30348463 | Result | 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. | |
| 30475959 |
Not provided
Not provided
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
The data is expected to be available after, December, 2020 and can be used forever
The information should be used for academic research, medical communication, etc., and is prohibited from being used for commercial gain.
Not provided
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C008315 | maltodextrin |
Not provided
Not provided
Not provided
| First Affiliated Hospital Xi'an Jiaotong University |
| OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| basic energy intake | Dietary Supplement | supplement as basic energy intake |
|
| maltodextrin | Dietary Supplement | used as placebo in the control group |
|
| 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 |
| 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. |