A Study About Nutritional Support of Enhanced Protein in Critical Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Dietary supplement: basic energy intake; Dietary supplement: maltodextrin; Dietary supplement: a production consist of various oligopeptides and the whey protein

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).

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Dalian Medical University; The Second Affiliated Hospital of Dalian Medical University; Yabao Pharmaceutical Group
• Investigators: Principal Investigator: Wei Chen, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 25, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: critical illness; protein; national support
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HS-2028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No