A Study About Nutritional Support of Enhanced Protein in Critical Patients

NCT04177446 | Unknown DMC

• 1 other identifier: HS-2028
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness

Keywords

national support; protein; critical illness

Outcome Measures

Primary Outcomes (2)

• urea nitrogen of 24h

  the total amount of urea nitrogen in 24 hours

  day6

• prealbumin(PA)

  the level of prealbumin in blood

  day6

Secondary Outcomes (9)

• total protein

  day6

• albumin

  day6

• calf circumference

  change from baseline calf circumference at 6 days

• grip

  change from baseline grip at 6 days

• overall complication rate

  from the day receiving enteral nutrition to day6

Study Arms (2)

control group

PLACEBO COMPARATOR

Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo

Dietary Supplement: basic energy intake; Dietary Supplement: maltodextrin

intervention group

EXPERIMENTAL

Patients will be given basic energy intake according to their weight, and will be extra protein intake

Dietary Supplement: a production consist of various oligopeptides and the whey protein; Dietary Supplement: basic energy intake

Interventions

a production consist of various oligopeptides and the whey protein DIETARY_SUPPLEMENT

patients will be given extra protein intake except the basic energy intake

intervention group

basic energy intake DIETARY_SUPPLEMENT

supplement as basic energy intake

control group; intervention group

maltodextrin DIETARY_SUPPLEMENT

used as placebo in the control group

control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ age ≤ 45;
• pattens volunteer to attend this study and sigh the inform consent form;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Yabao Pharmaceutical Group: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Related Publications (2)

• 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.

  PMID: 30348463 RESULT

• 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.

  PMID: 30475959 RESULT

MeSH Terms

Conditions

Critical Illness

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Chen

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Chen

CONTACT

+86(010)69154095; chenw@pumch.cn

Zhangping Yu

CONTACT

+86(010)69154095; yuzhangping1993@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: November 26, 2019
• Study Start: December 25, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data is expected to be available after, December, 2020 and can be used forever
• Access Criteria: The information should be used for academic research, medical communication, etc., and is prohibited from being used for commercial gain.