NCT00732849

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
Last Updated

August 12, 2008

Status Verified

July 1, 2008

Enrollment Period

3 months

First QC Date

August 5, 2008

Last Update Submit

August 8, 2008

Conditions

Gastrointestinal Surgery

Keywords

immunonutritionsurgical patientspostoperative period

Outcome Measures

Primary Outcomes (1)

  • Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients

    Immunonutrition

Secondary Outcomes (1)

  • To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay

    morbidity

Study Arms (4)

1

NO INTERVENTION

Standard Enteral Nutrition - Peptisorb, Nutricia Ltd.

Drug: Reconvan, Dipeptiven, Omegaven

2

NO INTERVENTION

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

Drug: Reconvan, Dipeptiven, Omegaven

3

EXPERIMENTAL

Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland

Drug: Reconvan, Dipeptiven, Omegaven

4

EXPERIMENTAL

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

Drug: Reconvan, Dipeptiven, Omegaven

Interventions

Reconvan, Dipeptiven, OmegavenDRUG

Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.

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Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of SUegy

Krakow, _30978, 307981, Poland

Location

MeSH Terms

Interventions

alanylglutaminefish oil triglycerides

Study Officials

  • Stanislaw Klek, MD, PhD

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 12, 2008

Study Start

June 1, 2002

Primary Completion

September 1, 2002

Study Completion

November 1, 2007

Last Updated

August 12, 2008

Record last verified: 2008-07

Locations

PL(1)