Back to resultsThe Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery
Primary Purpose
Gastrointestinal Surgery
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Reconvan, Dipeptiven, Omegaven
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Surgery focused on measuring immunonutrition, surgical patients, postoperative period
Eligibility 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
Sites / Locations
- 1st Department of SUegy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Standard Enteral Nutrition - Peptisorb, Nutricia Ltd.
Standard Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes
Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland
Immunomodulating Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes + Omegaven (Fresenius Kabi), Dipepitven (Fresenius Kabi)
Outcomes
Primary Outcome Measures
Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients
Secondary Outcome Measures
To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00732849
Brief Title
The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery
Official Title
The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Jagiellonian University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Surgery
Keywords
immunonutrition, surgical patients, postoperative period
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Standard Enteral Nutrition - Peptisorb, Nutricia Ltd.
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes
Arm Title
3
Arm Type
Experimental
Arm Description
Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland
Arm Title
4
Arm Type
Experimental
Arm Description
Immunomodulating Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes + Omegaven (Fresenius Kabi), Dipepitven (Fresenius Kabi)
Intervention Type
Drug
Intervention Name(s)
Reconvan, Dipeptiven, Omegaven
Intervention Description
Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.
Primary Outcome Measure Information:
Title
Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients
Time Frame
Immunonutrition
Secondary Outcome Measure Information:
Title
To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay
Time Frame
morbidity
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw Klek, MD, PhD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of SUegy
City
Krakow
State/Province
_30978
ZIP/Postal Code
307981
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery
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