Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study
Purpose Hypercatabolism and immune suppression are frequently seen in patients with
malignancy.Preoperative nutritional state is an important factor in determining surgical and
postoperative complications because the preoperative nutritional status affects the
postoperative nutritional state, immunity and inflammatory response.In these patients,
standard parenteral nutrition may not be sufficient to maintain the immunity and provide
positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with
immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T
lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor-
alfa.There is a report which showed that glutamine dipeptide supplemented parenteral
nutrition improved the cellular and humoral immune functions. The investigators aimed to
evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid
supplemented parenteral nutrition on the neutrophil functions and postoperative course of
patients with colorectal cancer.
Condition Intervention Phase Malnutrition Colorectal Cancer Dietary Supplement:
Immunonutrition Phase 4
Study Type: Interventional Study Design: Prevention, Parallel Assignment, Double Blind
(Subject, Investigator), Randomized, N/A
Official Title: Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty
Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And
Length Of Stay-A Double Blind,Controlled, Randomized Study
Primary Outcome Measure: Title: neutrophil functions Time Frame:
perioperative,postoperative third and seventh days for change in first seven days of
hospital stay Description: For comparison of four different nutrition on neutrophil
functions in first seven days of hospital stays.
Secondary Outcome Measures: Title: Length of stay Time Frame: Length of stay
(participants will be followed for the duration of hospital stay) for colorectal cancer
patients which are eligable for study study from january 2007 to january 2008 in one year
period.
Description: For comparison of four different nutrition on length of stay (participants
will be followed for the duration of hospital stay)
Actual Enrollment: 36 Study Start Date: January 2007 Actual Study Completion Date: January
2008 Actual Primary Completion Date: January 2008
Arms Assigned Interventions Active Comparator: Control an isocaloric and iso-nitrogenous
standard parenteral nutrition
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy
and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2
g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient
substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous
line
Experimental: Standard parenteral-glutamine (S-D) alanine-glutamine (aln-gln) (Dipeptiven)
supplemented parenteral nutrition (S-D group, n=8),
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy
and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2
g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient
substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous
line
Experimental: Standard-Omega-3 fatty acid (S-O) Omega-3 fatty acid (Omegaven) supplemented
parenteral nutrition (S-O group, n=8)
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy
and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2
g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient
substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous
line
Experimental: Standard-glutamine-omega 3 (S-D-O) ala-gln and omega 3 fatty ascid
supplemented parenteral nutrition (S-D-O group, n=10).
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy
and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2
g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient
substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous
line
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
neutrophil functions
For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
perioperative,postoperative third and seventh days for change in first seven days of hospital stay
Yes
Mustafa Dulger, Professor
Study Chair
Kocaeli University
Turkey: Ministry of Health
Canturkz1
NCT01831310
January 2007
January 2008
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