primary objective:-to define the optimal glucose intake by quantifying endogenous glucose production and fractional gluconeogenesis in critically ill children.secundary objectives:-determine glucose utilization in relation with exogenous glucose…
ID
Source
Brief title
Condition
- Other condition
- Congenital cardiac disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Health condition
ernstig zieke kinderen met verschillende aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-endogenous glucose production
-fractional gluconeogenesis
-glucose utilization
-whole body protein balance.
- fractional albumin synthesis rate.
Secondary outcome
indirect calorimetry:determination of total energy expenditure
urine samples for nitrogen excretion: protein utilization
anthropometry
Background summary
Hyperglycaemia is common in critically ill children. it has been associated
with increased morbidity and mortality in several studies of critically ill
children. Intensive insulin therapy reduces morbidity and mortality in
critically ill adults. The overall hypothesis is that critically ill children
will benefit as well from strict glucose control via insulin. it is becoming
increasingly evident that establishment of normoglycaemia and not the insulin
infusion perse, is responsible for the observed favourable results. a high
intravenous glucose input might be deleterious as it can induce hyperglycaemia.
No studies were performed in critically ill children to investigate the effect
of different regimens of glucose intake on endogenous glucose production and on
blood glucose concentration.
Study objective
primary objective:
-to define the optimal glucose intake by quantifying endogenous glucose
production and fractional gluconeogenesis in critically ill children.
secundary objectives:
-determine glucose utilization in relation with exogenous glucose intake and
endogenous glucose production.
-relate endogenous glucose response with the hormonal and inflammatory response.
-to determine the effect of different glucose infusion regimens on whole body
protein balance (synthesis - breakdown)
- to determine fractional albumin synthesis rate to get more insight in the
contribution of hepatic proteinsynthesis to whole body protein synthesis.
Study design
randomized crossover study with 2 regimens of exogenous glucose administered in
different groups of critically ill children on the PICU.
(protocol page 10 study design)
Intervention
One group will first get the lower amount of glucose infusion followed by the
higher amount. The other group will first get the higher amount of glucose
infusion followed by the lower amount.
They all will get 2 times 2 stable isotopes.
Study burden and risks
not specific more risks other then the normal risks on the PICU.
dr molenwaterplein 60
3015 gj rotterdam
NL
dr molenwaterplein 60
3015 gj rotterdam
NL
Listed location countries
Age
Inclusion criteria
-critically ill patients after elective surgery ( cardial, craniofacial of scoliosis surgery) admitted to the ICU
-critically ill patients with various medical diseases and > 1 organ failure admitted to the ICU.
- with arterial line
-inclusion 1 to 12 hours after admission
-cardiorespiratory stable
-only parental glucose after admission
Exclusion criteria
endocrine disorders, liver failure, chromosomal disorders,
insulin therapy
no arterial line of after removal arterial line
no informed consent
in case of patient after elective cardiac surgery: no extracorporal circulation during cardiac surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-006054-26-NL |
| CCMO | NL19433.078.08 |
| OMON | NL-OMON26665 |