Congenital Heart DiseasePhase 4NCT01368705
Nitrogen Balance in Infants After Post Cardiothoracic Surgery
A Phase 4 study testing Standard protein delivery, Intervention 1 (2.2g/kg/day) and Intervention 2 (3.0 g/kg/day) in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The objective is to the amount of protein infants require after cardiopulmonary bypass surgery. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Standard protein delivery, Intervention 1 (2.2g/kg/day) and Intervention 2 (3.0 g/kg/day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Jun 2012
- Phase
- Phase 4
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical decision to initiate parenteral nutrition based on determination by medical team
- Gestational age ≥ 35 weeks
- Birth weight ≥ 2000 grams
- Indwelling urinary catheters for urine collection
- Central venous access for parenteral nutrition
Who cannot join
- Chromosomal abnormalities known to effect protein metabolism
- Hepatic failure defined as ALT and AST > 500 UL with an INR > 2.5, not accounted for by therapeutic anticoagulation
- Renal failure defined as creatinine 2x the upper limit of normal for age.
- Sepsis or suspected sepsis, defined as clinical suspicion or confirmation of a systemic infection treated with antibiotics
- Excessive blood loss from chest tubes (5 ml/kg/hr) that has not resolved within six hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study
- Requiring Extra Corporeal Membrane Oxygenation (ECMO) support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery
The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.
Read the detailed description
Postoperative neonates are susceptible to the adverse effects of surgery that is characterized by a breakdown of body stores. Without appropriate nutritional consideration this process can lead to increased physiological instability. It has been extensively documented that critically ill patients are typically catabolic. This results in body nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as, gluconeogenesis. The evaluation of this catabolic response is particularly crucial in infants due to their limited fat and lean body mass reserves. Quantifying the amount of protein needed to maintain body composition and to meet the demands of surgical stress is of clinical importance when considering factors associated with postoperative morbidity, such as delayed wound healing, impaired growth and prolonged hospital stay.
The results obtained from this study will assist with determining an appropriate level of protein for the development of optimal nutrition prescriptions that are aimed at reducing catabolism of body stores.
- Conditions
- Congenital Heart Disease
- Being tested
- Standard protein delivery, Intervention 1 (2.2g/kg/day), Intervention 2 (3.0 g/kg/day)
- Keywords
- Infants, Nitrogen Balance, Cardiothoracic surgery, Congenital heart disease, Malnutrition
- Medical subject headings
- Heart Defects, Congenital, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard protein deliveryDietary supplement
Protein delivery of 1.5 g/kg/day.
Intervention 1 (2.2g/kg/day)Dietary supplement
protein delivery of 2.2g/kg/day
Intervention 2 (3.0 g/kg/day)Dietary supplement
protein delivery of 3.0 g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Dietary Supplement: Standard protein delivery |
| Intervention Group 1 | Experimental | Not described Receives: Dietary Supplement: Intervention 1 (2.2g/kg/day) |
| Intervention Group 2 | Experimental | Not described Receives: Dietary Supplement: Intervention 2 (3.0 g/kg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitrogen Balance
After an initial adaptation period of approximately 12 hours receiving parenteral nutrition the first 24-hour urine collection for nitrogen balance will be started; following this two successive 24-hour urine collections will be performed in order to obtain a three-day collection for nitrogen balance analyses.
Measured: From 0-84 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Pencharz, The Hospital for Sick Children
- Investigators
- Paul B Pencharz, MD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368705
- Sponsor's protocol ID
- 1000012920
- Status last verified
- Aug 2013
- First submitted
- 6 Jun 2011
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT01368705
- Acronym / sponsor ID
- 1000012920
- Conditions
- Congenital Heart Disease
- Keywords
- Infants, Nitrogen Balance, Cardiothoracic surgery, Congenital heart disease, Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Jun 2011 (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 objective is to the amount of protein infants require after cardiopulmonary bypass surgery.
Detailed description
Postoperative neonates are susceptible to the adverse effects of surgery that is characterized by a breakdown of body stores. Without appropriate nutritional consideration this process can lead to increased physiological instability. It has been extensively documented that critically ill patients are typically catabolic. This results in body nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as, gluconeogenesis. The evaluation of this catabolic response is particularly crucial in infants due to their limited fat and lean body mass reserves. Quantifying the amount of protein needed to maintain body composition and to meet the demands of surgical stress is of clinical importance when considering factors associated with postoperative morbidity, such as delayed wound healing, impaired growth and prolonged hospital stay.
The results obtained from this study will assist with determining an appropriate level of protein for the development of optimal nutrition prescriptions that are aimed at reducing catabolism of body stores.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Dietary Supplement: Standard protein delivery |
| Intervention Group 1 | Experimental | Dietary Supplement: Intervention 1 (2.2g/kg/day) |
| Intervention Group 2 | Experimental | Dietary Supplement: Intervention 2 (3.0 g/kg/day) |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical decision to initiate parenteral nutrition based on determination by medical team
- Gestational age ≥ 35 weeks
- Birth weight ≥ 2000 grams
- Indwelling urinary catheters for urine collection
- Central venous access for parenteral nutrition
Key exclusion criteria (6 listed)
- Chromosomal abnormalities known to effect protein metabolism
- Hepatic failure defined as ALT and AST > 500 UL with an INR > 2.5, not accounted for by therapeutic anticoagulation
- Renal failure defined as creatinine 2x the upper limit of normal for age.
- Sepsis or suspected sepsis, defined as clinical suspicion or confirmation of a systemic infection treated with antibiotics
- Excessive blood loss from chest tubes (5 ml/kg/hr) that has not resolved within six hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard protein deliveryProtein delivery of 1.5 g/kg/day. | Dietary supplement | Control Group |
| Intervention 1 (2.2g/kg/day)protein delivery of 2.2g/kg/day | Dietary supplement | Intervention Group 1 |
| Intervention 2 (3.0 g/kg/day)protein delivery of 3.0 g/kg/day | Dietary supplement | Intervention Group 2 |
Primary outcome
Nitrogen Balance
Time frame: From 0-84 hours
After an initial adaptation period of approximately 12 hours receiving parenteral nutrition the first 24-hour urine collection for nitrogen balance will be started; following this two successive 24-hour urine collections will be performed in order to obtain a three-day collection for nitrogen balance analyses.
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 19 Aug 2013.
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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.
Paul B Pencharz, MD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard protein delivery, Intervention 1 (2.2g/kg/day) and Intervention 2 (3.0 g/kg/day) in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
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 5 inclusion and 6 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 19 Aug 2013. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nitrogen Balance (time frame: From 0-84 hours). 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 19 Aug 2013.