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

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00732849
First received: August 5, 2008
Last updated: August 8, 2008
Last verified: July 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Gastrointestinal Surgery
 Drug: Reconvan, Dipeptiven, Omegaven
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients [ Time Frame: Immunonutrition ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay [ Time Frame: morbidity ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: June 2002
Study Completion Date: November 2007
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732849

Locations
Poland
1st Department of SUegy
Krakow, _30978, Poland, 307981
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Stanislaw Klek, MD, PhD Jagiellonian University
  More Information

No publications provided

Responsible Party: 1st Department of General Surgery, Jagiellonian University
ClinicalTrials.gov Identifier: NCT00732849     History of Changes
Other Study ID Numbers: surg nutr
Study First Received: August 5, 2008
Last Updated: August 8, 2008
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
immunonutrition
surgical patients
postoperative period

ClinicalTrials.gov processed this record on May 16, 2013