The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery - Full Text View

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:

MedlinePlus related topics: Malnutrition

U.S. FDA Resources

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:

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Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eysman L, Kesecioglu J. Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial. Lancet. 2001 Sep 1;358(9283):696-701.

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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 May 23, 2013