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Insulin and protein in critically ill children.


- candidate number6631
- NTR NumberNTR2060
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-okt-2009
- Secondary IDs28671.000.09 NL
- Public TitleInsulin and protein in critically ill children.
- Scientific TitleProtein and Energy Interactions in Critically Ill Children.
- ACRONYM
- hypothesisObjective:
1. To determine protein balance in septic, critically ill children at baseline and during a Hyperinsulinemic Euglycemic Clamp, while receiving standard or high protein intake based on age group;
2. To assess insulin sensitivity and response in critically ill septic children;
3. To assess the relationship between protein turnover and glucose and fat metabolism in critically ill septic children.
- Healt Condition(s) or Problem(s) studiedSepsis, Critically ill children
- Inclusion criteriaChildren admitted to the Pediatric Intensive Care Unit:
1. Diagnosis of SIRS, sepsis or septic shock, as determined by the criteria of the First International pediatric sepsis forum (Pediatric Critical Care Medicine 2005 vol 6 page 3-8);
2. Indwelling central venous access placed for clinical purpose;
3. Drawing line placed for clinical purpose;
4. Need for total parenteral nutritional support for at least 2 days.
- Exclusion criteria1. Patients with metabolic diseases i.e.: urea cycle disorders, cystinuria and insulin dependent diabetes mellitus;
2. Patients with hepatic or renal failure;
3. Enteral feeds providing more than 20% of total daily protein and energy intake based on age and weight;
4. Insulin therapy prior to the start of the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2009
- planned closingdate1-dec-2011
- Target number of participants30
- InterventionsStandard vs High Amino acid intake by means of Total Parenteral Nutrition for 24 hrs in a cross-over design. On both study days a primed , continuous stable isotope tracer infusion will be provided for 7 hrs, of which the last three hours will be with insulin infusion by means of a Hyperinsulinemic euglycemic Clamp.
- Primary outcomeWHole body Protein Balance.
- Secondary outcome1. Insulin resistance;
2. Glucose metabolism;
3. Lipolysis and Glycerol metabolism.
- Timepoints2 day study which starts once the subject is hemodynamically stable in the PICU. It consists of 7 hr tracer infusions of which the last 4 hrs will be with insulin infusion.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. S. Verbruggen
- CONTACT for SCIENTIFIC QUERIESMD. S. Verbruggen
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Sophia Foundation for Scientific Research
- PublicationsN/A
- Brief summaryIt has been reported that tight glucose control with insulin in adult critically ill surgical patients has reduced mortality rates. However, there is no evidence that this approach may be beneficial in critically ill children. In theory, insulin has several potential beneficial effects. It has metabolic effects (glycemic control, improve protein balance and dyslipidemia) and non-metabolic effects (protect against oxidative stress, endothelial dysfunction and regulation of inflammation). Under physiological conditions, there is a close interrelationship between protein and energy (glucose and fat) metabolism. An increase in the energy supply will not promote nitrogen retention unless the amino acid supply is adequate, and conversely an increased amino acid supply will be useless if energy is limiting. Furthermore, protein requirements in critically ill children reach beyond the traditional areas of nitrogen balance and protein metabolism. Individual amino acids exert a functional impact during critical illness on which insulin might have a significant effect. The effect of tight glucose control with insulin on protein requirements, and on the regulation of substrate metabolism in critically ill septic children of all ages needs further study.

Objective:
1. To determine protein balance in septic, critically ill children at baseline and during a Hyperinsulinemic Euglycemic Clamp, while receiving standard or high protein intake based on age group;
2. To assess insulin sensitivity and response in critically ill septic children;
3. To assess the relationship between protein turnover and glucose and fat metabolism in critically ill septic children.

Study design:
A prospective, translational study.

Study population:
Critically ill septic children.

Intervention:
The study consists of a 2 day, 7-hour primed continuous intravenous tracer infusion studies of which the last three hours will be with a HEC. The protocol will consist of a tracer study ([1-13C]Leucine, [ring-2H5]Phenylalanine and [3,3 2H2]Tyrosine, [6,6 2H2]Glucose and [1,1,2,3,3 2H5]Glycerol) on two days in which they will receive parenteral nutrition with two different amounts of protein intake (according to age) in a cross over fashion.

Main study parameters/endpoints:
The main study parameter of the study is the change in protein balance between baseline and insulin infusion.
- Main changes (audit trail)
- RECORD22-okt-2009 - 26-okt-2009


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