Back to resultsA Study About Nutritional Support of Enhanced Protein in Critical Patients
Primary Purpose
Critical Illness
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a production consist of various oligopeptides and the whey protein
basic energy intake
maltodextrin
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness focused on measuring national support, protein, critical illness
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
intervention group
Arm Description
Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo
Patients will be given basic energy intake according to their weight, and will be extra protein intake
Outcomes
Primary Outcome Measures
urea nitrogen of 24h
the total amount of urea nitrogen in 24 hours
prealbumin(PA)
the level of prealbumin in blood
Secondary Outcome Measures
total protein
the total protein level in blood
albumin
the level of albumin in blood
calf circumference
the perimeter of calf
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 )
overall complication rate
the over complication rate after receiving enteral nutrition
length of hospital stay
the overall time stay in hospital
cost in hospital
all the money paid in the hospital
liver function
the level of AST/ALT in blood
renal function
the level of creatinine in blood
Full Information
NCT ID
NCT04177446
First Posted
October 11, 2019
Last Updated
December 19, 2019
Sponsor
Peking Union Medical College Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT04177446
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
national support, protein, critical illness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Patients will be given basic energy intake according to their weight, and will be extra protein intake
Intervention Type
Dietary Supplement
Intervention Name(s)
a production consist of various oligopeptides and the whey protein
Intervention Description
patients will be given extra protein intake except the basic energy intake
Intervention Type
Dietary Supplement
Intervention Name(s)
basic energy intake
Intervention Description
supplement as basic energy intake
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
used as placebo in the control group
Primary Outcome Measure Information:
Title
urea nitrogen of 24h
Description
the total amount of urea nitrogen in 24 hours
Time Frame
day6
Title
prealbumin(PA)
Description
the level of prealbumin in blood
Time Frame
day6
Secondary Outcome Measure Information:
Title
total protein
Description
the total protein level in blood
Time Frame
day6
Title
albumin
Description
the level of albumin in blood
Time Frame
day6
Title
calf circumference
Description
the perimeter of calf
Time Frame
change from baseline calf circumference at 6 days
Title
grip
Description
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 )
Time Frame
change from baseline grip at 6 days
Title
overall complication rate
Description
the over complication rate after receiving enteral nutrition
Time Frame
from the day receiving enteral nutrition to day6
Title
length of hospital stay
Description
the overall time stay in hospital
Time Frame
from date of admission in the hospital until the date of discharge, up to 1 year
Title
cost in hospital
Description
all the money paid in the hospital
Time Frame
from date of admission in the hospital until the date of discharge, up to 1 year
Title
liver function
Description
the level of AST/ALT in blood
Time Frame
day6
Title
renal function
Description
the level of creatinine in blood
Time Frame
day6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Chen
Phone
+86(010)69154095
Email
chenw@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangping Yu
Phone
+86(010)69154095
Email
yuzhangping1993@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Chen
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
The data is expected to be available after, December, 2020 and can be used forever
IPD Sharing Access Criteria
The information should be used for academic research, medical communication, etc., and is prohibited from being used for commercial gain.
Citations:
PubMed Identifier
30348463
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.
Results Reference
result
PubMed Identifier
30475959
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.
Results Reference
result
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A Study About Nutritional Support of Enhanced Protein in Critical Patients
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