|- candidate number||8079|
|- NTR Number||NTR2334|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-mei-2010|
|- Secondary IDs||09.1762 / P09.202 ; CCMO / CME|
|- Public Title||Effects of a short-term high protein diet on protein metabolism and physical stress response in children after cardiac surgery.|
|- Scientific Title||Effects of short-term high protein intake on protein synthesis and breakdown, and stress response in children after cardiac surgery.|
|- hypothesis||In young children after cardiac surgery, negative protein balance can be prevented (balance=0) with high protein intake (5 g/kd/day) compared to normal protein intake (2 gr/kg/d).|
|- Healt Condition(s) or Problem(s) studied||Cardiac surgery, Protein energy malnutrition, Stress response|
|- Inclusion criteria||1. Congenital heart disease (tricuspid valve atresia, pulmonary atresia, right ventricular hypoplasia) with planned surgical Glenn or Fontan procedure;|
2. Extra-corporeal circuit during surgery;
3. Age: 3-48 months at time of surgery;
4. Venous and arterial access after surgery.
|- Exclusion criteria||1. Prematurity < 37 weeks;|
2. Diabetes mellitus;
3. Inability to reach maximal enteral nutrition within 12 hours post surgery;
4. Clinical signs of infection with positive blood culture, and body core temperature > 38,5°C for > 4 hours;
5. Inotropic support other/more than: Milrinone 1,0 mcg/kg/min, Dobutamine 10 mcg/kg/min, and Norepinephrine 0,2 mcg/kg/min.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||3-jul-2010|
|- planned closingdate||3-jan-2012|
|- Target number of participants||24|
|- Interventions||3-day, postoperative, enteral continuous drip feeding with 5 gr/kg/d protein intake (intervention group), compared to 2 gr/kg/d protein intake (control group). Both groups receive a caloric intake of 160% of predicted by the Schofield equation, with carbohydrate intake of 6 mg/kg/min, and the remainder of calories supplied by fat.|
|- Primary outcome||1. Total body Ra [1-13C]valine;|
2. Total body valine oxidation;
3. Nonoxidative disposal valine;
4. Dndogenous Ra [1-13C]valine;
5. Valine balance;
6. Ra [15N2]urea in plasma;
7. Whole body net nitrogen retention.
|- Secondary outcome||Serum concentrations of:|
5. IL 6-8-10;
|- Timepoints||1. T=0: 4,2 mL blood for background enrichment 13-C + stress response; 20 mL expired air background enrichment 13-C (duplo);|
2. T=27,5: 20 mL expired air for enrichment 13-C (duplo);
3. T=45,50': 20 mL expired air for enrichment 13-C (duplo); 3,5 mL blood for enrichment 13-C and 15-N;
4. T=46: cf T=45,50' + insuline, cortisol, BUN, IL 6-8-10, CBG, TNFa, glucose;
5. T=46,10': cf T=45,50'.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| V.G.M. Geukers|
|- CONTACT for SCIENTIFIC QUERIES|| V.G.M. Geukers|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Nutricia Nederland B.V., Leiden University Medical Center (LUMC)|
|- Brief summary||Country of recruitment: Netherlands.
In critical illness, hypermetabolic stress response markedly increases whole body protein breakdown with concomitant lesser increase of protein synthesis, resulting in negative nitrogen balance and loss of lean body mass. Clinically this contributes to a higher morbidity and mortality, more ventilator days and increased length of stay on an Intensive Care Unit. Stimulation of synthesis of whole body protein improves protein balance. In adults, maximum protein synthesis capacity is 1.5-1.7 g•kg-1•d-1. In chronically catabolic, stunted children protein balance is increased by a dietary protein intake of 5 g•kg-1•d-1. Data on optimal protein intake in critically ill children is lacking.
Furthermore it has been suggested that several nutrients like glutamine, arginine, nucleotides and polyunsaturated fatty acids have beneficial effects on the stress response.
To measure the effect of a high protein diet on whole body protein synthesis and –breakdown, as well as on net whole body protein balance and production of urea in children after cardiac surgery.
To measure the effect of a high protein diet on the post-operative hypermetabolic stress response.
24 children who will undergo a cardiac surgery procedure will be randomly allocated in two groups of 12 before their surgery. Both groups receive an isocaloric diet during 3 days by nasogastric tube starting direct postoperatively with a protein load of 2 g•kg-1•d-1 (NP) or 5 g•kg-1•d-1 (HP). On day 3 whole body protein synthesis and –breakdown rates are measured by infusion of stable isotopes and collection of blood- and breath samples. Also determinants of post-operative stress response will be measured in the bloodsamples.
Blood- and breath samples will be collected for measurements on protein metabolism at set times at the start and during the study period of 3 days via arterial/venous catheters and tubes which are already present. The main parameters are: total body Ra [1-13C]valine, total body valine oxidation, nonoxidative disposal valine, endogenous Ra [1-13C]valine, Ra [15N2]urea in plasma, whole body net nitrogen retention
Plasma parameters stress response:
Insulin, glucose, cortisol, CBG, CRP, IL 6-8-10, and TNF-á.
|- Main changes (audit trail)|
|- RECORD||20-mei-2010 - 5-jun-2010|