Critically IllNCT01511354
New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children
An observational study of Critically Ill, run by Texas A&M University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Critically Ill
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Stable critically ill children admitted to the Pediatric Intensive Care Unit or Cardiovascular Intensive Care Unit of ACH
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: 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.
- Conditions
- Critically Ill
- Keywords
- critically ill children, ICU, 24hr protein balance, stable isotopes, fed state
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical care | Standard nutritional therapy and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body protein synthesis rate
Whole body protein synthesis rate in the fed state
Measured: 24 hours
Secondary outcomes (6)
Whole body protein breakdown rate
Whole body protein breakdown rate in the fed state
Measured: 24 hours
Whole body protein breakdown rate
Whole body myofibrillar protein breakdown rate in the fed state
Measured: 24 hours
Whole body Arginine production rate
Net whole body arginine production rate in the fed state
Measured: 24 h
Splanchnic amino acid extraction
Splanchnic amino acid extraction in the fed state
Measured: 24 hr
Urea production
Whole body urea production in the fed state
Measured: 24 hr
Plasma amino acid levels
Plasme amino acid level in the fed state
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startFeb 2008
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle P Engelen, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511354
- Sponsor's protocol ID
- 101653
- Status last verified
- Oct 2017
- First submitted
- 12 Jan 2012
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
de Betue CTI, Garcia Casal XC, van Waardenburg DA, Schexnayder SM, Joosten KFM, Deutz NEP, Engelen MPKJ. 24-Hour protein, arginine and citrulline metabolism in fed critically ill children - A stable isotope tracer study. Clin Nutr. 2017 Jun;36(3):876-887. doi: 10.1016/j.clnu.2016.12.023. Epub 2017 Jan 4.
PubMed 28089618
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children
- ClinicalTrials.gov ID
- NCT01511354
- Acronym / sponsor ID
- 101653
- Conditions
- Critically Ill
- Keywords
- critically ill children, ICU, 24hr protein balance, stable isotopes, fed state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Study start
- Feb 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard clinical care | – | –Standard nutritional therapy and treatment |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Stable critically ill children admitted to the Pediatric Intensive Care Unit or Cardiovascular Intensive Care Unit of ACH
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole body protein synthesis rate
Time frame: 24 hours
Whole body protein synthesis rate in the fed state
6 secondary outcomes
Whole body protein breakdown rate
Time frame: 24 hours
Whole body protein breakdown rate
Time frame: 24 hours
Whole body Arginine production rate
Time frame: 24 h
Splanchnic amino acid extraction
Time frame: 24 hr
Urea production
Time frame: 24 hr
Plasma amino acid levels
Time frame: 24 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Derived from this study: PubMed 28089618de Betue CTI, Garcia Casal XC, van Waardenburg DA, Schexnayder SM, Joosten KFM, Deutz NEP, Engelen MPKJ. 24-Hour protein, arginine and citrulline metabolism in fed critically ill children - A stable isotope tracer study. Clin Nutr. 2017 Jun;36(3):876-887. doi: 10.1016/j.clnu.2016.12.023. Epub 2017 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle P Engelen, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body protein synthesis rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01511354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.