A Study About Nutritional Support of Enhanced Protein in Critical Patients

Not Applicable

• Conditions: Critical Illness
• Interventions: Dietary Supplement: a production consist of various oligopeptides and the whey protein; Dietary Supplement: maltodextrin; Dietary Supplement: basic energy intake

• Registration Number: NCT04177446
• Lead Sponsor: Peking Union Medical College Hospital

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).

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20
• Study Start: 2019-12-25
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	a production consist of various oligopeptides and the whey protein	Patients will be given basic energy intake according to their weight, and will be extra protein intake
control group	maltodextrin	Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo
intervention group	basic energy intake	Patients will be given basic energy intake according to their weight, and will be extra protein intake
control group	basic energy intake	Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo

Primary Outcome Measures

Name	Time	Method
urea nitrogen of 24h	day6	the total amount of urea nitrogen in 24 hours
prealbumin(PA)	day6	the level of prealbumin in blood

Secondary Outcome Measures

Name	Time	Method
albumin	day6	the level of albumin in blood
overall complication rate	from the day receiving enteral nutrition to day6	the over complication rate after receiving enteral nutrition
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
total protein	day6	the total protein level 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 )