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Energy Expenditure in Burn ChildrenTEENCT01544868

Total Energy Expenditure, Protein Kinetics, and Body Composition in Recovering Burn Children.

A study testing Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover in people with Energy Expenditure in Burn Children and Protein Turnover in Burn Children, run by Shriners Hospitals for Children at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to measure resting energy expenditure, total energy expenditure, and physical activity in recovering burn children to better understand their relation to impaired growth and nutritional status; and to measure whole body and muscle protein turnover during recovery from burn injury to… Read more about this study

Who is it for?
Ages 2 to 18 years
What is being tested?
Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Nov 2011to Jan 2013
Phase
Interventional
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 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients > 2 less than 18 who have been admitted to our hospital for treatment of an initial wound size of 40% or greater total body surface area burn, which has subsequently healed

Who cannot join

  • hemodynamically unstable
  • not receiving enteral nutrition

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Shriners Hospitals For Chidren

    Boston, Massachusetts, 02446

Other trials in United States

About this study

Official title: Total Energy Expenditure, Protein Kinetics and Body Composition During Recovery From Severe Burn Injury in Children.

The purpose of this study is to measure resting energy expenditure, total energy expenditure, and physical activity in recovering burn children to better understand their relation to impaired growth and nutritional status; and to measure whole body and muscle protein turnover during recovery from burn injury to understand their impact on body composition and energy metabolism. It also aims to look at changes in lean body mass, fat mass, bone mineral density and bone mineral content during rehabilitation and during early convalescence.

Read the detailed description

Measures of total and resting energy expenditure, protein turnover, body composition and other nutritional and outcome-based measures will be made in patients receiving inpatient rehabilitative care for their burn injury. Patients will consist of acutely burned patients initially admitted to our hospital with burns of 40% of their total body, who have recently recovered from their acute phase of injury and have achieved wound closure as defined by less than 5% open wound area (Group A). In addition, patients admitted to the hospital for "acute rehabilitation", which includes patients in need of rehabilitative therapy will also be included. This latter group (Group B) is unique in that the patients may have open wound areas remaining due to difficulty healing, however are not critically ill. Group B may differ from the typical rehabilitation population seen at our hospital because of their open wounds and because they received care for their initial injury elsewhere. They are included here due to their apparent nutritional compromise and their unique energy and protein requirements that are difficult to predict according to our clinical experience. These patients are most likely to require artificial nutrition support and will benefit from information gained by this study.

Measurements will be made at baseline as defined at the time of wound closure (or at the time of admission for Group B). Subsequent measures will be done as follows: 1) total energy expenditure will be assessed weeks 1-3 and again at weeks 7-9. During weeks 1 and 7, protein turnover studies will take place. Indirect calorimetry and physical activity measures will take place on 2 consecutive days during each week. Lean body mass measurements will be done at the time of wound closure and at discharge. The study will end at the time of discharge.

Resting and total energy expenditure will be done using indirect calorimetry for resting energy expenditure and the doubly labeled water method for total energy expenditure. Briefly, the methodology for doubly labeled water is as follows. Two pre-dose urine specimens will be collected prior to an oral dose containing 0.22 g/kg total body water of 100% 18O water (or 1.2 g/kg per body weight of 10% 18O water) and 0.11 g/kg per body weight of 99.9% deuterium oxide. Three post-dose urine voids will be collected, followed by collection of a morning urine void daily for 7 days. Total energy expenditure by this method will represent the average energy expenditure over a 21-day period. It will be obtained at weeks 1-3 and again at weeks 7-9 weeks during the rehabilitative phase. Resting energy expenditure will be determined using indirect calorimetry by a metabolic cart on 2 consecutive days of each week. Physical activity will be determined by having the patients wear an physical activity monitor (Actical Physical Monitoring System, mini-Mitter, Co., Inc, Bend Oregon) on their wrist, ankle or hand for the entire day twice a week (corresponding to the metabolic cart measurement). This will be worn on 2 days of each week. Protein nutritional status and turnover will be measured using N15 glycine. Three methyl-histidine will be measured at the time of N15 glycine studies (weeks 1 and 7) to assess the contribution of muscle mass to protein turnover. On the day of tracer study, each patient will provide a urine sample, and this urine sample will be collected to determine the basal level of N15 enrichment in urea and ammonia. Then the patient will receive a single dose (4mg/kg, less than 2% of normal daily intake of 1.1g per person) of 15N glycine tracer. For this, patients will drink a dose of 15N glycine (4mg.kg 1dissolved in 20 ml of saline) mixed in 50 cc of apple juice or other liquid beverage, followed by a 50 cc wash of water. 24 hour urine collection will commence immediately. Twenty-four hour urines will be used for determining the 15N NH3 and 15N urea enrichment. Each urine container will contain 5 ml of 15N HCl for trapping the urinary ammonium. Urine will be collected each day for 3 days, for determination of the total urinary nitrogen, urea creatinine, and ammonia excretion.

Lean body mass, fat mass and bone mineral density and content will be determined at baseline (or at the time of wound closure- as is routine care) and at discharge. Body composition components (lean body mass, fat mass and bone mineral density) will be determined for the lumbar spine and the whole body using dual energy x-ray absorptiometry (DXA) with a Discovery QDR 4500 A (Hologic, Waltham, MA) in burned and healthy children. Scanning will be performed by study staff trained and certified in the use of DXA. DXA uses x-ray beams at two photon energies to estimate body composition. Prior to the scan, height will be measured at the time of each measurement session with the subjects standing barefoot and in light clothing using a stadiometer. Measures will be recorded to the nearest 0.5 centimeters respectively. Weight will be taken using a balance scale and recorded to the nearest 0.5 kilograms. DXA measurements will be done by having the patient lie flat on his or her back on the DXA scanning table. Subjects will be positioned by the scanner so that the spine is straight on the table pad. For the lumbar spine measurement, a knee positioner will be placed under the patient's lower legs so that the patient's knees and hip are at a 90 degree angle. To align the C-arm (scanning arm ) of the DXA, a laser line will be positioned 1-2 inches below the patient's ileac crest, centered around the patient's midline. The scan time approximates 10 seconds, exposure is 0.38 mRem. For the whole body scan, the subject will lay on his or her back with their body straight, arms at sides, palms down, separated from thighs. The scanner will rotate the subject's legs inward 25 degrees until the toes touch, using tape around the feet to maintain this position. The subject will be instructed to breathe normally. The total scan time approximates 2.5 to 3.5 minutes with an exposure of 0.26 mRem. Total body fat and lean body mass will be determined by the DEXA as described as part of the whole body bone mineral density scan (only 1 scan session required). Measures of % body fat content and % lean body mass content for the whole body will be obtained using the DEXA software. These values will be compared to age and sex matched pediatric reference data for body composition {{217 Ellis, K.J. 2000; }}.

Because measures of LBM can be confounded by hydration status, a second measure of LBM using bioelectrical impedance will be made at these points and compared.

Being tested
Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover
Keywords
Total Energy Expenditure, Protein Balance, Burns
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of Stable Isotope to Measure Energy Expenditure and Protein TurnoverOther

    Two pre-dose urine specimens will be collected prior to an oral dose containing 0.22 g/kg total body water of 100% 18O water (or 1.2 g/kg per body weight of 10% 18O water) and 0.11 g/kg per body weight of 99.9% deuterium oxide. Then the patient will receive a single dose (4mg/kg, less than 2% of normal daily intake of 1.1g per person) of 15N glycine tracer. For this, patients will drink a dose of 15N glycine (4mg.kg 1dissolved in 20 ml of saline) mixed in 50 cc of apple juice or other liquid beverage, followed by a 50 cc wash of water. 24 hour urine collection will commence immediately. Twenty-four hour urines will be used for determining the 15N NH3 and 15N urea enrichment. Each urine container will contain 5 ml of 15N HCl for trapping the urinary ammonium. Urine will be collected each day for 3 days, for determination of the total urinary nitrogen, urea creatinine, and ammonia excretion.

Study groups in NCT01544868
Study groupRoleWhat they receive
Energy expenditure measurementOtherDescriptive measurements
Receives: Other: Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Energy Expenditure

    Tota Energy Expenditure will be determined in this group of burn children

    Measured: 4 years

Secondary outcomes (1)
  1. Protein Turnover

    Protein synthesis and breakdown will determined by stable isotope methodology

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544868
Sponsor's protocol ID
2006P001559
Acronym
TEE
Status last verified
Aug 2014
First submitted
29 Feb 2012
Last updated
20 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover in people with Energy Expenditure in Burn Children and Protein Turnover in Burn Children, run by Shriners Hospitals for Children 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 1 inclusion and 2 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 20 Aug 2014. 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?

Total Energy Expenditure (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Aug 2014.

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