The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Undernutrition Clinical Trial

Official title:

The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559520
• Other study ID #: PHRC 2004
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2007
• Last updated: December 8, 2011
• Start date: February 2002
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Dietary Supplement:
• Impact
Patient receiving 3 drinks "Impact" a day during 5 days before surgery
• Oral Impact
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

Locations

Country	Name	City	State
France	CHU de NICE, Department of Vascular Surgery	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Novartis

Country where clinical trial is conducted

France, 

References & Publications (23)

Arora NS, Rochester DF. Respiratory muscle strength and maximal voluntary ventilation in undernourished patients. Am Rev Respir Dis. 1982 Jul;126(1):5-8. — View Citation

Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. — View Citation

Beale RJ, Bryg DJ, Bihari DJ. Immunonutrition in the critically ill: a systematic review of clinical outcome. Crit Care Med. 1999 Dec;27(12):2799-805. — View Citation

Bower RH, Cerra FB, Bershadsky B, Licari JJ, Hoyt DB, Jensen GL, Van Buren CT, Rothkopf MM, Daly JM, Adelsberg BR. Early enteral administration of a formula (Impact) supplemented with arginine, nucleotides, and fish oil in intensive care unit patients: results of a multicenter, prospective, randomized, clinical trial. Crit Care Med. 1995 Mar;23(3):436-49. — View Citation

Braunschweig C, Gomez S, Sheean PM. Impact of declines in nutritional status on outcomes in adult patients hospitalized for more than 7 days. J Am Diet Assoc. 2000 Nov;100(11):1316-22; quiz 1323-4. — View Citation

Chima CS, Barco K, Dewitt ML, Maeda M, Teran JC, Mullen KD. Relationship of nutritional status to length of stay, hospital costs, and discharge status of patients hospitalized in the medicine service. J Am Diet Assoc. 1997 Sep;97(9):975-8; quiz 979-80. — View Citation

Evoy D, Lieberman MD, Fahey TJ 3rd, Daly JM. Immunonutrition: the role of arginine. Nutrition. 1998 Jul-Aug;14(7-8):611-7. Review. — View Citation

Gallagher-Allred CR, Voss AC, Finn SC, McCamish MA. Malnutrition and clinical outcomes: the case for medical nutrition therapy. J Am Diet Assoc. 1996 Apr;96(4):361-6, 369; quiz 367-8. Review. — View Citation

Gianotti L, Braga M, Frei A, Greiner R, Di Carlo V. Health care resources consumed to treat postoperative infections: cost saving by perioperative immunonutrition. Shock. 2000 Sep;14(3):325-30. — View Citation

Gianotti L, Braga M, Nespoli L, Radaelli G, Beneduce A, Di Carlo V. A randomized controlled trial of preoperative oral supplementation with a specialized diet in patients with gastrointestinal cancer. Gastroenterology. 2002 Jun;122(7):1763-70. — View Citation

Heyland DK, Novak F, Drover JW, Jain M, Su X, Suchner U. Should immunonutrition become routine in critically ill patients? A systematic review of the evidence. JAMA. 2001 Aug 22-29;286(8):944-53. Review. — View Citation

Heymsfield SB, Bethel RA, Ansley JD, Gibbs DM, Felner JM, Nutter DO. Cardiac abnormalities in cachectic patients before and during nutritional repletion. Am Heart J. 1978 May;95(5):584-94. — View Citation

Heys SD, Walker LG, Smith I, Eremin O. Enteral nutritional supplementation with key nutrients in patients with critical illness and cancer: a meta-analysis of randomized controlled clinical trials. Ann Surg. 1999 Apr;229(4):467-77. — View Citation

Hill GL, Blackett RL, Pickford I, Burkinshaw L, Young GA, Warren JV, Schorah CJ, Morgan DB. Malnutrition in surgical patients. An unrecognised problem. Lancet. 1977 Mar 26;1(8013):689-92. — View Citation

Johnson JA, Cogbill TH, Strutt PJ, Gundersen AL. Wound complications after infrainguinal bypass. Classification, predisposing factors, and management. Arch Surg. 1988 Jul;123(7):859-62. — View Citation

Kirk SJ, Barbul A. Role of arginine in trauma, sepsis, and immunity. JPEN J Parenter Enteral Nutr. 1990 Sep-Oct;14(5 Suppl):226S-229S. Review. — View Citation

Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta-analysis of controlled trials. BMJ. 2001 Oct 6;323(7316):773-6. — View Citation

Melchior JC. [How to assess preoperative nutritional status?]. Ann Fr Anesth Reanim. 1995;14 Suppl 2:19-26. French. — View Citation

Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6. — View Citation

Robinson G, Goldstein M, Levine GM. Impact of nutritional status on DRG length of stay. JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):49-51. — View Citation

Spark JI, Robinson JM, Gallavin L, Gough MJ, Homer-Vanniasinkam S, Kester RC, Scott DJ. Patients with chronic critical limb ischaemia have reduced total antioxidant capacity and impaired nutritional status. Eur J Vasc Endovasc Surg. 2002 Dec;24(6):535-9. — View Citation

Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eÿsman 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. — View Citation

Wu D, Meydani SN. n-3 polyunsaturated fatty acids and immune function. Proc Nutr Soc. 1998 Nov;57(4):503-9. Review. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		before surgery, five days and thirty days after surgery	No
Primary	Arisen of an infectious complication		during the period of 30 days following the surgery	No
Primary	Arisen of non infectious complication		during the period of 30 days following the surgery	No
Secondary	Primary and secondary permeability		at 5 and 30 days after surgery	No
Secondary	Pain		at 5 and 30 days after surgery	No
Secondary	Healing		at 5 and 30 days after surgery	No