New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children

Critically Ill Clinical Trial

Official title:

Development of New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511354
• Other study ID #: 101653
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: October 10, 2017
• Start date: February 2008
• Est. completion date: January 2013

Study information

• Verified date: October 2017
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body protein synthesis rate	Whole body protein synthesis rate in the fed state	24 hours
Secondary	Whole body protein breakdown rate	Whole body protein breakdown rate in the fed state	24 hours
Secondary	Whole body protein breakdown rate	Whole body myofibrillar protein breakdown rate in the fed state	24 hours
Secondary	Whole body Arginine production rate	Net whole body arginine production rate in the fed state	24 h
Secondary	Splanchnic amino acid extraction	Splanchnic amino acid extraction in the fed state	24 hr
Secondary	Urea production	Whole body urea production in the fed state	24 hr
Secondary	Plasma amino acid levels	Plasme amino acid level in the fed state	24 hr