A Study About Nutritional Support of Enhanced Protein in Critical Patients

Critical Illness Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04177446
• Other study ID #: HS-2028
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: May 2020

Study information

• Verified date: December 2019
• Source: Peking Union Medical College Hospital
• Contact: Wei Chen
• Phone: +86(010)69154095
• Email: chenw[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. diagnosed as critical illness, stayed in ICU;

2. score of M-nutric = 5;

3. score of 3. APACHE ? >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;

Related Conditions & MeSH terms

• Critical Illness

Intervention

Dietary Supplement:
• a production consist of various oligopeptides and the whey protein
patients will be given extra protein intake except the basic energy intake
• basic energy intake
supplement as basic energy intake
• maltodextrin
used as placebo in the control group

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Dalian Medical University, Yabao Pharmaceutical Group

References & Publications (2)

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 h — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urea nitrogen of 24h	the total amount of urea nitrogen in 24 hours	day6
Primary	prealbumin(PA)	the level of prealbumin in blood	day6
Secondary	total protein	the total protein level in blood	day6
Secondary	albumin	the level of albumin in blood	day6
Secondary	calf circumference	the perimeter of calf	change from baseline calf circumference at 6 days
Secondary	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
Secondary	overall complication rate	the over complication rate after receiving enteral nutrition	from the day receiving enteral nutrition to day6
Secondary	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
Secondary	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
Secondary	liver function	the level of AST/ALT in blood	day6
Secondary	renal function	the level of creatinine in blood	day6