The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery

Jagiellonian University

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Surgery

Treatments: Drug: Reconvan, Dipeptiven, Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT00732849

surg nutr

Details and patient eligibility

About

The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery

Full description

All patients qualified between June 2002 and December 2007 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Malnutrition was defined by the Nutritional Risk Index (NRI), calculated according to the formula used in the Veterans Administration Cooperative Group trial.{, 1991 #70} Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients without features of malnutrition, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.

Enrollment: 600 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age between 18 and 80 years,
• Karnofsky performance status score of 80 or more,
• adequate organ function measured by routine blood tests

Exclusion criteria

• patients <18 or > 80
• Karnofsky performance < 50

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

1

No Intervention group

Description:

Standard Enteral Nutrition - Peptisorb, Nutricia Ltd.

Treatment:

Drug: Reconvan, Dipeptiven, Omegaven

2

No Intervention group

Description:

Standard Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes

Treatment:

Drug: Reconvan, Dipeptiven, Omegaven

3

Experimental group

Description:

Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland

Treatment:

Drug: Reconvan, Dipeptiven, Omegaven

4

Experimental group

Description:

Immunomodulating Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes + Omegaven (Fresenius Kabi), Dipepitven (Fresenius Kabi)

Treatment:

Drug: Reconvan, Dipeptiven, Omegaven