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Trial record 1 of 1 for:    NCT01511354
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New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children

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ClinicalTrials.gov Identifier: NCT01511354
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : October 11, 2017
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Brief Summary:
The need for certain components of food (i.e. protein) for critically ill children is not clear. It is important to have critically ill children fed adequately to prevent that their condition becomes worse or that recovery takes longer. Research methods used in the past to investigate the need for protein (Nitrogen Balance calculations), were not sensitive enough in severely ill children. The purpose of this study is to develop a new research method to determine the need for protein in severely ill children. In order to develop this new method, more information is needed on the way the body of these children uses protein in 24-hours. In the present study during 24-hours 8 children of age less than 18 years who are admitted to either the Pediatric ICU or the Cardiovascular ICU. Subjects will receive a standard nutrition, providing an age specific amount of protein (age ≤ 3: 2.52 protein g/kg BW.d; age 4-6: 1.8 protein g/kg BW.d; age > 10: 1.44 protein g/kg BW.d) via tube feeding. They will also receive a mixture of stable isotopes of amino to investigate protein behavior in the body (protein kinetics) both by infusion in their blood and together with the nutrition. Blood will be drawn every 60 minutes during the 24-hour period and the behavior of protein and the concentrations in blood of amino acids and urea will be measured. Urine will be collected to measure nitrogen balance. The investigators will compare the results of this nitrogen balance method with the results of the stable isotope method. PIM2, PRISM, SIRS criteria will be used to get information on the severity of illness of the subjects. Also body weight and length as well as body composition of the subjects will be measured at the start and after the 24-hour period. Body composition will be measured by Bioelectrical Impedance Spectroscopy. Endpoints of the study are net whole-body protein synthesis (protein balance), 24-hour pattern of protein balance, 24-hour urea production, 24-hour nitrogen balance, 24-hour contribution of arginine kinetics to whole body protein breakdown, 24-hour muscle protein breakdown, splanchnic amino acid extraction and plasma amino acid concentrations.

Condition or disease
Critically Ill

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children
Study Start Date : February 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Standard clinical care
Standard nutritional therapy and treatment

Primary Outcome Measures :
  1. Whole body protein synthesis rate [ Time Frame: 24 hours ]
    Whole body protein synthesis rate in the fed state

Secondary Outcome Measures :
  1. Whole body protein breakdown rate [ Time Frame: 24 hours ]
    Whole body protein breakdown rate in the fed state

  2. Whole body protein breakdown rate [ Time Frame: 24 hours ]
    Whole body myofibrillar protein breakdown rate in the fed state

  3. Whole body Arginine production rate [ Time Frame: 24 h ]
    Net whole body arginine production rate in the fed state

  4. Splanchnic amino acid extraction [ Time Frame: 24 hr ]
    Splanchnic amino acid extraction in the fed state

  5. Urea production [ Time Frame: 24 hr ]
    Whole body urea production in the fed state

  6. Plasma amino acid levels [ Time Frame: 24 hr ]
    Plasme amino acid level in the fed state

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable critically ill children admitted to the Pediatric Intensive Care Unit or Cardiovascular Intensive Care Unit of ACH

Inclusion Criteria:

  1. Critically ill children with age less than 18 years at the time of enrollment
  2. Admitted to the Pediatric ICU or Cardiovascular ICU, with an expected stay of >72 hours
  3. One arterial line (or umbilical arterial line) and one multi-lumen central venous line (or two peripheral venous catheters) in place.
  4. Continuous total parenteral nutrition or continuous enteral feeding (e.g. via nasogastric, nasoduodenal, gastric, jejunal tube) with standard nutrition appropriate for age and weight expected during admission.
  5. No planned major changes or interventions (such as surgery) in the treatment and care of the patient from enrollment to completion of study period (end of 24-hour stable isotope infusion protocol).
  6. Hemodynamic stable condition (with or without continuous inotropic medication) defined as ≤1 boluses of volume resuscitation for hypotension in 24 hour.
  7. No significant loss of plasma/blood from wounds or drains, that may influence the results of the study, no chylothorax.
  8. Informed consent by parent(s) or LAR.

Exclusion Criteria:

  1. Congenital/acquired metabolic or endocrine disorders or hepatic or renal failure or anuria or oliguria.
  2. Gastrointestinal obstructions or any condition that causes malabsorption.
  3. Active gastro-intestinal bleeding.
  4. Fluid restriction (<100 ml/kg BW.day) making administration of intravenous and enteral stable isotopes impossible.
  5. Any other condition that according to the Principal Investigator or study physician would interfere with collecting study samples (for example isolation due to MRSA infection).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511354

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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Texas A&M University
Arkansas Children's Hospital Research Institute
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Principal Investigator: Marielle P Engelen, PhD University of Arkansas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT01511354    
Other Study ID Numbers: 101653
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Keywords provided by Marielle PKJ Engelen, PhD, Texas A&M University:
critically ill children
24hr protein balance
stable isotopes
fed state
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes