Status:
COMPLETED
New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children
Lead Sponsor:
Texas A&M University
Collaborating Sponsors:
Arkansas Children's Hospital Research Institute
Conditions:
Critically Ill
Eligibility:
All Genders
Up to 18 years
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 ...
Eligibility Criteria
Inclusion
- Critically ill children with age less than 18 years at the time of enrollment
- Admitted to the Pediatric ICU or Cardiovascular ICU, with an expected stay of \>72 hours
- One arterial line (or umbilical arterial line) and one multi-lumen central venous line (or two peripheral venous catheters) in place.
- 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.
- 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).
- Hemodynamic stable condition (with or without continuous inotropic medication) defined as ≤1 boluses of volume resuscitation for hypotension in 24 hour.
- No significant loss of plasma/blood from wounds or drains, that may influence the results of the study, no chylothorax.
- Informed consent by parent(s) or LAR.
Exclusion
- Congenital/acquired metabolic or endocrine disorders or hepatic or renal failure or anuria or oliguria.
- Gastrointestinal obstructions or any condition that causes malabsorption.
- Active gastro-intestinal bleeding.
- Fluid restriction (\<100 ml/kg BW.day) making administration of intravenous and enteral stable isotopes impossible.
- 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).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01511354
Start Date
February 1 2008
End Date
January 1 2013
Last Update
October 11 2017
Active Locations (1)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202