The change of serum prealbumin levels and serum protein markers between, egg white powder and casein protein additives in standard enteral feeding formulas, in critically ill patients with acute respiratory failure
Study ID: TCTR20160126002
Current status: Completed
Last Updated: May 17, 2016
Tracking Information
Date of Registration in Primary Registry: January 26, 2016
Date of First Enrollment: January 04, 2014 (Actual)
Target Sample Size: 34
Last Updated Date: May 17, 2016
Primary Outcome(s):
  • Outcome name: To determine the change of serum prealbumin levels between egg white powders compared to casein addi
       Metric/method of measurement: serum prealbumin (mg%)
       Time point: 7 days
       Safety Issue?: No


  • Key Secondary Outcomes:
  • Outcome name: to determine the change of inflammatory markers, including C-reactive protein (CRP), Erythrocyte Sed
       Metric/method of measurement: ESR and CRP measurement
       Time point: 7 days
       Safety Issue?: No


  • Descriptive Information
    Public Title: The change of serum prealbumin levels and serum protein markers between, egg white powder and casein protein additives in standard enteral feeding formulas, in critically ill patients with acute respiratory failure
    Scientific Title: The change of serum prealbumin levels and serum protein markers between, egg white powder and casein protein additives in standard enteral feeding formulas, in critically ill patients with acute respiratory failure
    Brief Summary: There is no different of prealbumin levels changes between two groups.
    Detailed Description:
    Study Design: Allocation: Randomized controlled trial
    Control: Active
    Study Endpoint Classification: Bio-equivalence Study
    Intervention Model: Parallel
    Number of Arms: 2
    Masking: Double Blind (Masked Roles: Subject, Caregiver, Investigator)
    Primary Purpose: Treatment
    Study Phase: Phase 2
    Health Condition(s) or Problem(s) Studied: -Patient with acute respiratory failure , -Enteral feeding , -Standard feeding formulas 1500 Kcal
    Study Arms:
  • Arm: 1
  • Intervention Name: Egg White powders
    Type: Active Comparator
    Classification: Dietary Supplement
    Descriptions: Add Egg White powders 40 grams to standard feeding formulas of 1500 Kcal
  • Arm: 2
  • Intervention Name: Casein Protein
    Type: Active Comparator
    Classification: Dietary Supplement
    Descriptions: Add casein protein 40 gm to standard feeding formulas 1500 Kcal
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 34
    Study Start Date (First enrollment): January 04, 2014
    Primary Completion Date: August 31, 2014
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum 100 Years
    patients with acute respiratory failure who required invasive mechanical ventilation age 18 year old along with initiation of early enteral nutrition within 48 hours after admission
    Exclusion Criteria
    an expected time of less than five consecutive days for nasogastric tube feeding required top up parenteral nutrition morbid obesity BMI 30 kg m2 renal failure requiring renal replacement therapy hepatic dysfunction total bilirubin 3 mg immune suppressive conditions eg AIDS chronic steroid use 2 weeks on immunosuppressive drugs malignancy patients that currently received chemotherapy or radiation therapy pregnancy and those with a history of egg white allergies
    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Rungsun Bhurayanontachai
    Phone: 0815990583
    Email: rungsun2346@gmail.com
    Postal Address: Medical ICU, Songklanagarind Hospital
    State/Province: Hat Yai/Songkhla        Postal Code: 90110
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20160126002
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: nil
    Study Primary Sponsor: nil
    Study Secondary Sponsor: 1.) nil
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Rungsun Bhurayanontachai
    Phone: 0815990583
    Email: rungsun2346@gmail.com
    Postal Address: Medical ICU, Songklanagarind Hospital
    State/Province: Hat Yai/Songkhla        Postal Code: 90110
    Country: Thailand
    Track changes

    Copyright  © 2009. Medical Research Foundation, Thailand. All Rights Reserved.