An observational study in Critically Ill, sponsored by Texas A&M University. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by Texas A&M University · Observational
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 12 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Stable critically ill children admitted to the Pediatric Intensive Care Unit or Cardiovascular Intensive Care Unit of ACH
Exclusion Criteria:
Standard nutritional therapy and treatment
Whole body protein synthesis rate
Whole body protein synthesis rate in the fed state
Time frame: 24 hours
Whole body protein breakdown rate
Whole body protein breakdown rate in the fed state
Time frame: 24 hours
Whole body protein breakdown rate
Whole body myofibrillar protein breakdown rate in the fed state
Time frame: 24 hours
Whole body Arginine production rate
Net whole body arginine production rate in the fed state
Time frame: 24 h
Splanchnic amino acid extraction
Splanchnic amino acid extraction in the fed state
Time frame: 24 hr
Urea production
Whole body urea production in the fed state
Time frame: 24 hr
Plasma amino acid levels
Plasme amino acid level in the fed state
Time frame: 24 hr
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Texas A&M University