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Chapter 5

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The RCT by Larsen et al., as well as the post-hoc analysis of this RCT, investigated 32 infants

undergoing elective open-heart surgery with cardiopulmonary bypass and compared the

effect of the pre- and post-operative administration of two types of parenteral lipid formulas,

namely Intralipid® (LCT soybean oil) in the control group and Lipoplus® (50% MCT, 40% LCT,

10% Fish oil) in the intervention group

11,17

. In the primary trial

17

, the authors report significantly

lower plasma concentrations of TNF-alpha and IL-6 (primary outcome measures) on the first

postoperative day in the treatment group receiving Lipoplus®. On day 7, the plasma TNF-

alpha and IL-6 concentrations were no longer different. Also duration of stay in PICU/hospital,

incidence of sepsis, inotrope scores or ventilator days (secondary outcome measures) were

similar in both groups. The post-hoc analysis

11

also reported lower levels of other inflammation

biomarkers (procalcitonin, leukotriene B4, lymphocytes) in the Lipoplus® group.

Two RCTs by Chaloupecky et al. were studies of 29 and 37 infants, respectively, undergoing

cardiac surgery, in which the impact on proteolysis and plasma amino acid profiles of early

parenteral administration of a higher dose of amino acids and of glucose as compared with

a low dose maintenance glucose infusion on the first postoperative day was investigated

10,12

.

Thereafter, all patients received enteral nutrition in equal amounts. The authors reported

less negative nitrogen balances, less proteolysis as suggested by urinary 3-methylhistidine

excretion, and higher levels of plasma amino acids during the first postoperative day in the

intervention group who received more parenteral amino acids and glucose. Although clinical

outcome measures were not explicitly described, the authors report no severe complications

such as low cardiac output syndrome, renal failure, sepsis or mortality in any of the groups.

Duration of intubation and inotropic support did not differ between treatment groups.

The RCT by Jordan et al. investigated 98 children suffering from severe sepsis or admitted

after major surgery who were identified as requiring parenteral nutrition. The study compared

the impact of glutamine-supplemented parenteral nutrition in the intervention group

with standard parenteral nutrition in the control arm

13

. The authors report that glutamine-

supplemented parenteral nutrition evoked a higher plasma concentration of heat shock

protein 70 on day 5, whereas plasma concentrations of IL-6 and IL-10 were not affected. Clinical

outcome measures were not significantly different in the 2 study groups.

The RCT by Lekmanov et al. studied 40 children with severe thermic burns and concomitant

injuries and compared the effect of glutamine-supplemented total parenteral nutrition during

at least one week in the intervention group to standard total parenteral nutrition in the control

group

14

. The authors reported no significant differences between the two groups for the serum

levels of protein, albumin and glutamine on day 5 and 7 of PICU stay, but found a significantly

shorter duration of mechanical ventilation in the intervention group (7 days versus 12 days in

the control group). This result should be interpreted with caution, since the methods section

was incomplete without information on the statistical analyses. Also plasma concentrations of

glutamine were not significantly different between the two groups.