The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00559520
First received: November 14, 2007
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

The role of preoperative oral immunonutrition in major vascular surgery.

The mean purpose of this study was to determine the prevalence of post-operative infection complications after major vascular surgery in group of patients with preoperative oral immunonutrition.

This group was compared to a control group.

Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on postoperative mortality (30 days), the medium length of stay in the hospital and the cost of treatment in the two groups


Condition Intervention Phase
Undernutrition
Dietary Supplement: Impact
Dietary Supplement: Oral Impact
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Official Title: The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Weight [ Time Frame: before surgery, five days and thirty days after surgery ] [ Designated as safety issue: No ]
  • Arisen of an infectious complication [ Time Frame: during the period of 30 days following the surgery ] [ Designated as safety issue: No ]
  • Arisen of non infectious complication [ Time Frame: during the period of 30 days following the surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Primary and secondary permeability [ Time Frame: at 5 and 30 days after surgery ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: at 5 and 30 days after surgery ] [ Designated as safety issue: No ]
  • Healing [ Time Frame: at 5 and 30 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: February 2002
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Impact
patient receiving 3 drinks "Impact" a day during 5 days before surgery
Dietary Supplement: Impact
Patient receiving 3 drinks "Impact" a day during 5 days before surgery
Experimental: Oral Impact
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery
Dietary Supplement: Oral Impact
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intervention planned since at least 5 days before surgery
  • Duration of hospitalization of at least 5 days

Exclusion Criteria:

  • Pregnant or lactating woman
  • Patient with severe renal insufficiency
  • Patient under 18 years old
  • Patient infected with HIV,hépatitis B or C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559520

Locations
France
CHU de NICE, Department of Vascular Surgery
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Novartis
Investigators
Principal Investigator: Michel BATT, Professeur Department of Vascular Surgery, CHU de NICE
  More Information

Publications:

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00559520     History of Changes
Other Study ID Numbers: PHRC 2004
Study First Received: November 14, 2007
Last Updated: December 8, 2011
Health Authority: France: Direction Générale de la Santé
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
Patients
Suffering
Undernutrition
Requiring
Vascular
Surgery

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on April 23, 2014