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

The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Surgery
• Intervention / Treatment: Drug: Reconvan, Dipeptiven, Omegaven

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • _30978
    • Krakow, _30978, Poland, 307981
      • 1st Department of SUegy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; Standard Enteral Nutrition - Peptisorb, Nutricia Ltd.	Drug: Reconvan, Dipeptiven, Omegaven; Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.
No Intervention: 2; Standard Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes	Drug: Reconvan, Dipeptiven, Omegaven; Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.
Experimental: 3; Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland	Drug: Reconvan, Dipeptiven, Omegaven; Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.
Experimental: 4; Immunomodulating Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes + Omegaven (Fresenius Kabi), Dipepitven (Fresenius Kabi)	Drug: Reconvan, Dipeptiven, Omegaven; Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients	Immunonutrition

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay	morbidity

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Principal Investigator: Stanislaw Klek, MD, PhD, Jagiellonian University

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): September 1, 2002
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 8, 2008
• First Posted (Estimate): August 12, 2008

Study Record Updates

• Last Update Posted (Estimate): August 12, 2008
• Last Update Submitted That Met QC Criteria: August 8, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: immunonutrition; surgical patients; postoperative period
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: surg nutr