New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 10/13/2017 |
| Start Date: | February 2008 |
| End Date: | January 2013 |
Development of New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children
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.
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.
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).
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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